Fresenius -- Granuflo-- were patients harmed?Register Today!
- by anurseadvocate May 29, '12Recently, on the internet, a major renal website published information about FMC's Granuflo. FMC internal memos were made public with comments from the individual who published this information... Also, the FDA published warning was made public. I am wondering what you all think about this,,, your feelings?
Here is the information that was posted ---the is the 'second' of which was posted --
Background on Recent Focus on Sudden Cardiac Death
In April 2009, a 4-day conference titled “ESRD: State of the Art and Charting the Challenges for the Future” was held in Boston (conference report and steering committee letter). The main purpose of the conference was to address the lack of improvement in dialysis patient survival over the last twenty years. At that meeting, sudden cardiac death was identified as the #1 cause of death for dialysis patients, accounting for 59% of cardiovascular-related deaths.
At the end of the conference, a novel finding was reached. It was concluded that these cardiovascular-related deaths were not due primarily to atherosclerotic (plaques and arterial stiffening) disease, but rather uremic cardiomyopathy, characterized by left ventricular hypertrophy (LVH), LV dysfunction, and LV dilatation. The enlarged muscle walls of the left ventricle become fibrotic and fail to conduct electrical impulses correctly due to repeated and continual fluid overloads in the body (most dialysis patients don’t produce urine). The conference’s conclusions have driven many efforts involving several leading nephrologists to reduce sodium levels in dialysate, end sodium profiling, improve body water volume control, and more.
Among the many members of the steering committee of the conference was Raymond Hakim, MD, PhD, then Chief Medical Officer of Fresenius Medical Care North America (FMC). The Boston conference’s findings regarding sudden cardiac death appear to have driven investigations within FMC. This is very evident in the 6-page internal memo from Fresenius Medical Services (FMS) to FMC’s medical directors and attending physicians dated November 4, 2011. The memo’s subject line is “RE: Dialysate Bicarbonate, Alkalosis, and Patient Safety.” While the memo does not bear his name, Dr. Hakim was head of the FMS at that time. This memo refers to a FMCNA analysis, a case-control study that evaluated risk factors in hemodialysis patients who suffered from cardiopulmonary arrest in the dialysis facility compared to other hemodialysis patients within the same facilities between Jan. 1 and Dec. 31, 2010.
This case-control study identified 941 patients in 667 FMC facilities between Jan. 1 and Dec. 31, 2010 that had cardiopulmonary (CP) arrests within the facilities. Looking at the data for these 941 patients, the study found a 4.7 times higher risk (adjusted) of CP arrest with pre-dialysis bicarbonate levels >28mEq/L. If the patient also had a pre-dialysis potassium that was <4 mEq/L, they had a 6.3 times higher (adjusted) risk of CP arrest.
Before 2011, alkalosis, routinely measured via serum bicarbonate levels, had not been seen a significant problem for hemodialysis patients. An earlier non-FMC study (2001-2003, DaVita data) showed some survival benefit with pre-dialysis bicarbonate levels >24 mEq/L.
Working Hypothesis and/or Preliminary Concern Stage
The internal FMS memo released Nov. 4 contains several references to FMS efforts and programs to educate its medical staff on this issue starting in January 2011. Before the results of the case-control study were published by FMS on Nov. 4, 2011, there were likely preliminary data analyses, as well as internal communications and educational programs done as part of a preliminary concern or working hypothesis stage.
The Nov.4 memo mentions that several memos had previously been sent to FMC staff explaining the differences between Naturalyte® and Granuflo®, both FMC acid concentrate products. It also states that recommendations had previously been made to address pre-dialysis alkalosis found in an increasing number of patients. The Nov. 4 memo specifically states that this problem was mentioned in the Medical Staff Newsletter in January 2011 and that two recent presentations by FMC personnel were available for download from the “Doctors Corner.”
It appears that the FMS division of FMC concluded in October or early November 2011 that their internal data supported a conclusion that a significant risk of cardiopulmonary arrest existed for patients with the use of Granuflo. It was no longer simply a working hypothesis. On Nov. 4, 2011, the FMS office released the 6-page memo, entitled “Dialysate Bicarbonate, Alkalosis, and Patient Safety,” that emphatically stated the need to take action if a patient’s pre-dialysis serum bicarbonate was >28 mEq/L and especially if the patient also had a pre-dialysis serum potassium of <4 mEq/L. It also recommended “immediate attention to decreasing the prescribed dialysate bicarbonate in patients with pre-dialysis bicarbonate level of >24 mEq/L.
Statements and Warnings Regarding Alkalosis in the Internal FMC Memo
The memo begins with a one paragraph conclusion:
"Recent analyses performed using FMCNA hemodialysis (HD) patient safety data confirms that alkalosis is a significant risk factor associated with cardiopulmonary (CP) arrest in the dialysis unit, independent of and additive to the risk of CP arrest associated with pre-dialysis hypokalemia. The major cause of metabolic alkalosis in dialysis patients is inappropriately high dialysate total buffer concentration. As recommended in previous communications, physicians should individualized dialysate bicarbonate and total buffer prescriptions. We further recommend that predialysis serum bicarbonate level of >24 mEq/L should prompt immediate review of dialysate bicarbonate prescription."Some excerpts from the “summary of findings:”
“The current analysis determined that: “borderline elevated pre-dialysis bicarbonate levels and over alkalosis are significantly associated with 6 to 8 fold greater increase of cardiopulmonary arrest and sudden cardiac death in the dialysis facility.” “ (italic type emphasis is theirs)The recommendations section of the memo begins by stating that “pre-dialysis alkalosis and hypokalemia are modifiable risk factors associated with CP arrest.” The memo urges that this issue “needs to be addressed urgently.”
“In light of these troubling findings, we strongly recommend that physicians adjust dialysate bicarbonate prescriptions monthly for individual patients, with immediate attention to patients with serum pre-dialysis bicarbonate level of >24 mEq/L.”
The memo acknowledges that many facilities have converted to Fresenius powdered Granuflo formulations and that the total buffer level equals “prescribed bicarbonate plus 8.” It continues:
“There are instances whereby the physicians’ bicarbonate prescriptions were kept the same when shifting to power (sic) concentrate (Granuflo) (failing to account for the additional 8 mEq/L of sodium acetate), thus exposing patients to a higher total buffer load than intended. While 60% of current dialysate prescriptions are for 37 mEq/L of bicarbonate, it may be prudent to initially target a prescription of 31-33 mEq/L of dialysate bicarbonate (with total buffer greater by up to ~8 mEq/L from acetate) and adjust accordingly to patients’ monthly bicarbonate level. Please recall also that an additional source of bicarbonate may be the phosphate binders that are prescribed to patients.”Among the ten cited references at the end of the memo are two medical articles that include “sudden death” in their titles. Another is entitled, “The faster potassium-lowering effect of high dialysate bicarbonate concentrates in chronic hemodialysis patients.”
Failure to Notify Either the FDA or Non-FMC Dialysis Centers Using Granuflo
As noted earlier, Granuflo with sodium diacetate had been approved for marketing by the FDA in 2003. The problem with Granuflo, alkalosis, and sudden cardiac death was apparently not suspected until many years later, apparently around 2010.
Currently there are over 5700 dialysis centers and approximately 400,000 dialysis patients in the United States. It is estimated that 3300 of these clinics use Granuflo formulations and that approximately 260,000 patients are using the product. It is estimated that slightly less than half these patients, or approximately 125,000 patients, are using Granuflo in non-FMC clinics. Total revenues from Granuflo sales per year in the U.S. are estimated at a minimum of $80 million.
If a company fails to notify the FDA of a known problem with an FDA-approved medical device, it can result in severe fines and penalties, including being prohibited from marketing products for use in facilities that treat Medicare patients.
It is believed that the FDA received information concerning the alkalosis problem with Granuflo, most likely the internal FMC memo dated Nov. 4, in early 2012 from an anonymous source. The FDA then contacted all four dialysis concentrate manufacturers, FMC, Rockwell Medical, Diasol and Minntech Renal Systems, for information on this topic on March 27, 2012.
There is no evidence that FMC attempted to contact either the FDA or any of the non-FMC clinics until March 29, 2012. On that date, the FMC medical products division provided a 2-page memo to non-FMC clinics that used much of the same language from the FMS division memo of Nov. 4, 2011. The memo from the medical products division, however, lacked most of the detail and all of the urgency of the FMC internal memo of Nov. 4, 2011 on the same topic.
- The March 29 memo only included four medical resources on its reference list. The March 29 memo included only one of the ten references used in the FMC internal memo of Nov. 4. One of the references on the March 29 memo only was for 2001-2003 data that showed a benefit of pre-dialysis serum bicarbonate levels of >24 mEq/L. (CJASN 2006 1:70-78)
- No references in the March 29 memo mentioned sudden death or the rapid removal of potassium during dialysis treatments with high bicarbonate levels in their titles.
Dr. Raymond Hakim Steps Down as FMC Medical Director
As previously mentioned, Dr. Raymond Hakim was the medical director of FMS on Nov. 4, 2011 and was likely responsible for the FMS internal memo released on that date. As Chief Medical Officer, it would seem logical that Dr. Hakim would also notify his non-physician superiors at FMC, Ben Lipps and (Mau)Rice Powell, of his decision to release the Nov 4, 2011 internal FMC memo. He would likely also have recommended that the medical products division of FMC notify their other customers, the non-FMC clinics, of the FMS findings so these non-FMC clinics could make the best decisions for their patients regarding the use of Granuflo.
Neither Lipps nor Powell are physicians (current FMC management board members).
Six days after the internal memo was released, the annual meeting of the American Society of Nephrology (ASN) was held in Philadelphia (Nov. 10-12). At that meeting, there was a Dialysis Outcomes Practice Patterns Study (DOPPS) presentation (click here) on bicarbonate levels and dialysis patient mortality. It concluded that there was an increase in patient mortality with total buffer levels above 37 mEq/L.
It appears that Dr. Hakim left Philadelphia more convinced than ever that non-FMC clinics needed to be notified of his finding concerning Granuflo, alkalosis, and CP arrests. It would seem logical that Dr. Hakim would become more adamant in his requests that the product division of FMC do this as soon as possible.
On Nov. 16, 2011, a press release appeared from FMCNA stating that Dr. Raymond Hakim was stepping down as FMC Medical Director as of December 12, 2011. It was also announced that he would be replaced by Dr. Frank Maddux.
Did FMC Put Market Share and Profit before Patient Safety?It appears that Fresenius Medical Care (FMC) knew as early as 2010 that there may be a link between high total buffer levels and the risk of cardiac arrest. In its response to the Part I posting on RenalWEB about this issue, FMC said it didn’t believe it had enough information to share the potential risks of Granuflo with its customers:
""In this case, with respect to 'total buffer,' the Chief Medical Office distributed to FMS medical directors a working hypothesis relating to dialysate mix products in general, but also specifically citing our products Granuflo and Naturalyte, that -- pending further data collection, analysis, and development -- might or might not eventually support conclusions warranting general external or peer reviewed publication."But is there not a dangerous conflict of interest for a company that treats patients and makes the products as well? When clinical experts bump heads with those who want to protect market share and protect profit margins, who makes the final decision?
FMC started as a products company; its top two executives, who are not physicians but instead medical product sales and development experts, may have, in this case, agreed to address these medical concerns with their own patients, but hesitated about informing their customers, possibly fearing loss of market share and possible litigation. As a result, with the current FMC medical product oversight policies, it appears that non-physician FMC executives can now make important medical decisions concerning dialysis patients in non-FMC clinics.
Clearly, the two-page memo sent to customers was devoid of much of the information in the internal memo. It was purposely made vague, when the evidence was crystal clear: high pre-dialysis serum bicarbonate levels created a risk of cardiac arrest and deaths. FMC wanted to limit its risk and, at the same time, not scare off customers.
This is a story not about just one physician's conflict of interest, but about multiple persons' conflicts of interest in a vertically-integrated, for-profit healthcare corporation. All these conflicts of interest had a multiplying effect, resulting in risks and dangers for patients that are at a minimum, highly unacceptable, and at worst, criminal.
Many of the hypotheses in this article cannot be confirmed due to corporate confidentiality policies and the non-disclosure clauses of employment and/or employment termination contracts. Only congressional hearings or an investigation by the HHS Office of the Inspector General can bring these facts to light.
A group of dialysis clinic medical directors of a large dialysis provider corporation with approximately 13,000 patients held a regularly scheduled meeting on Friday, May 11, 2012. One of topics for discussion was the 2-page, March 29 memo from FMC. One physician who had reviewed the document said that the memo's "conclusion was not supported by the memo's references." The group decided to take no patient-specific action, but did decide to choose to draw post-dialysis serum bicarbonate levels on some patients, with the results to be discussed at a later time.
Unrelated to this, I received copies of both the internal and external FMC memos on Saturday, May 12. Within a hour of receiving them, I contacted the CEO of this large dialysis provider. He then had one of his physicians who had privileges at an FMC clinic obtain a copy of the internal FMC 6-page memo dated Nov. 4.
After reading the 6-page memo, these medical directors decided to meet again on Monday, May 14. At that meeting, they decided to intervene in approximately 20% of their patients' care. On Tuesday, May 15, patient-specific changes were implemented for over 2000 patients.
- May 29, '12 by anurseadvocatethis is the part one of the above __ again, wondering what you all think about this -- my concerns are that other providers, who use fmc products might not have been notified of this ---
cardiac arrest is a devastating complication of hemodialysis treatments. renalweb obtained a copy of an internal memo from fresenius medical care north america (fmc) dated nov. 4, 2011 that indicates that fmc had knowledge that there was a significant increased risk of cardiac arrest and death during hemodialysis treatments associated with their granuflo® dialysis concentrate product that contains sodium diacetate. top fmc officials knew about the source of this potential problem since the product’s introduction in 2003. when a clinical problem finally became evident to the fresenius medical services division around 2010, it appears that the top fmc executives not only chose not to properly report this problem to the fda and other government agencies, but that they also decided to withhold this information from non-fmc physicians and clinics that were using the granuflo product. it appears there was collusion involving individuals in several fmc departments and organizations to hide, mislead, and obscure information about this patient safety hazard in order to maintain their market share as well as to minimize and diffuse the legal risks for fmc. also possibly related to this situation, the chief medical officer of fmc, raymond hakim, md, phd, abruptly left his position in a november 2011 announcement.
fresenius medical care north america is the largest division of fresenius medical care ag, headquartered in germany, and is the largest dialysis services and products company in both the u.s. and the world. fmc is uniquely vertically integrated in its business environment in that fmc both owns thousands of dialysis clinics and it also manufactures the dialysis machines and nearly all the medical products used in dialysis care including dialyzers, blood lines, needles, dialysis concentrate, etc. fmc has separate business divisions for clinic operations and for product manufacturing and sales. the fmc products division “sells” products not only to its own clinics’ division, but also to many of its leading competitors, including davita, dci, renal ventures, and many others.
when the possible correlation between granuflo use, alkalosis, and cardiopulmonary arrest was finally made by the fresenius medical services division around 2010, fmc made this information and urgent medical recommendations solely available to its own physicians and clinics. sudden cardiac death is the leading cause of death for dialysis patients. the internal fmc memo specifically recommended action for patients with pre-dialysis bicarbonate levels of >28meq/l and especially for those who also had pre-dialysis serum potassium levels of <4 meq/l. this 6-page internal fmc memo shows that for at least 15 months, fmc did not share this information with the thousands of non-fmc physicians and clinics that were using the granuflo product. it then appears that fmc received an inquiry on march 27, 2012 from the fda specifically about granuflo-related products and alkalosis. only then did fmc provide a scientifically-ambiguous, 2-page memo with far less actionable information to its non-fmc customers on march 29, 2012. the march 29 memo did not mention any patient blood levels. the most at-risk population of all, “acute” dialysis patients, are not mentioned in either memo.
the march 29th memo to non-fmc clinics and physicians contained only one of ten medical references that the fmc internal memo did. the march 29th memo also bundled the risks of granuflo with another fmc acid concentrate product, naturalyte®. the march 29th memo to non-fmc clinics and physicians also had a "reply form" attached that requested that a clinic representative sign it to "confirm that i have received and read the information presented to me in the accompanying letter regarding the risk of alkalosis with naturalyte® liquid and granuflo® acid concentrates."
since its introduction in 2003, the granuflo product has steadily increased its market share. it is now used by the majority of nearly 400,000 hemodialysis patients in the u.s. in the internal fmc memo, granuflo use is associated with increased serum bicarbonate levels and alkalosis, as well as the increased possibility of cardiopulmonary arrests. also in the internal fmc memo, fresenius medical services noted that its own patients’ serum pre-dialysis bicarbonate levels had gradually increased from 2004 to 2011. despite fms’s knowledge of this patient safety risk, more non-fmc clinics are being converted to the granuflo product even today without knowledge of the risks that are made clear in the internal fmc memo. despite these patient safety issues and possible federal trade commission violations and penalties, the fmc product sales division continues to aggressively market the product and routinely bundles granuflo with other fmc products for pricing discounts.
the strategy that fmc executives seemed to arrive at to remedy this situation without either being noticed or without losing market share seems to take two approaches, one for fmc clinics and one for non-fmc clinics. fmc physicians and clinics were being instructed to remedy the situation immediately by making large changes to the hemodialysis machine settings, a somewhat inelegant solution that could raise other clinical problems for some patients. fmc physicians who questioned the change and wanted to use a different product could be dissuaded with a number of tactics. this may raise anti-trust issues.
for non-fmc clinics, it appears that fmc officials were hoping to quickly attain fda approval of a new product that contained citric acid instead of sodium diacetate. citric acid products are gaining in popularity in hemodialysis clinics because they appear to provide a number of additional clinical benefits. while fmc does currently license a citric acid product from another company, it is highly priced for a low-volume niche patient market and it also contains acetate. it appears that the fmc officials were planning to switch non-fmc granuflo customers primarily to its new citric acid product as soon as it was fda approved. the additional clinical benefits of the citric acid product could easily be touted as the justification for the widespread switch without raising too many questions in non-fmc clinics. the granuflo product could then be discontinued or relaunched with far better clinician education programs.
if non-fmc clinics knew of the problem, they likely would have demanded further explanations, and many would have switched to other companies’ products. these non-fmc clinics also would likely not have discouraged affected patients and their families from pursuing legal actions.
intriguingly, unbeknownst to thousands of u.s. nephrologists, fmc may have shifted some of its liability for this product to nephrologists by utilizing fmc personnel’s leadership positions on industry standard-setting committees. fmc is the only company that markets a granuflo-related product with sodium diacetate. the association for the advancement of medical instrumentation (aami)’s committee for renal disease and detoxification is co-chaired by a fmc renal therapies group employee. in recent years, language concerning the sodium di-acetate and uncertain bicarbonate levels was inserted into the aami standards for dialysis. as the medicare conditions of coverage hold the physicians responsible for providing dialysis care that adheres to aami standards, these nephrologists may unknowingly share legal responsibility for alkalosis resulting from the use of granuflo.
background information on dialysate and granuflo
dialysate is the solution that passes through the artificial kidney to clean the blood during hemodialysis. the dialysate is continuously mixed and heated within the dialysis machine during a hemodialysis treatment. dialysate is a mixture of three fluids: ultrapure water, bicarbonate concentrate, and acid concentrate. bicarbonate concentrate contains sodium bicarbonate mixed in ultrapure water. acid concentrate adds additional sodium, as well as the needed potassium, calcium, magnesium, and the acid/acetate. levels of all these components must be carefully controlled.
the granuflo acid concentrate powder product from fresenius medical care (fmc) received fda approval for marketing in 2003. this product allows dialysis clinics to mix their own acid concentrate solutions using ultrapure water and packets of dry chemicals, the “granuflo” formulations. by mixing their own acid concentrates, clinics can lower shipping costs and storage space associated with traditional 55 gallon drums. fmc also sells traditional, pre-mixed, liquid acid concentrate formulations under the brand name “naturalyte.”
to control the ph of the dialysate, all acid concentrates must contain an acid and/or a form of acetate. traditionally, most products have used acetic acid, which is liquid. granuflo formulations are the only marketed products to contain the “dry” powder form of acetic acid, sodium diacetate. recently, an increasing number of dialysis clinics have begun using citric acid products as evidence has been increasing that its use provides a number of clinical benefits.
acidosis, bicarbonate and total buffer levels
patients requiring dialysis normally suffer from acidosis, a buildup of acid in their blood. this is corrected (buffered/neutralized) during hemodialysis treatments with bicarbonate from two sources. the first and main source is the bicarbonate from the bicarbonate concentrate. bicarbonate in the dialysate passes through the membrane of the artificial kidney and into the patient’s blood.
the second source of bicarbonate for the patient is the acetate in the acid concentrate. this acetate actually performs two functions. most importantly, it controls the final ph level of the dialysate solution. secondly, acetate also passes into the patient’s blood, where it is rapidly converted into bicarbonate by the patient’s tissues/liver.
a new term, total buffer level, refers to both bicarbonate and acetate in the dialysate. if there are 33 meq/l from the bicarbonate concentrate and 4 meq/l of acetate from the acid concentrate, the total buffer level is 37 meq/l. disparities between the prescribed dialysate bicarbonate levels, total buffer levels, and bicarbonate settings and readings on the dialysis machines have been an ignored long-term problem in dialysis care. until very recently, almost all dialysis care professionals – as well as the fda and cms surveyors – did not consider the effects of the acetate in the acid concentrate when prescribing bicarbonate levels.
recently discovered problem of widespread alkalosis… and its possible causes
evidence is now showing that a significant percentage of dialysis patients have unexpectedly high levels of bicarbonate in their blood and are actually suffering from alkalosis, the opposite of acidosis. the association between higher dialysate bicarbonate levels, pre-dialysis serum bicarbonate levels, and increased mortality was the topic of a presentation at the annual meeting of the american society of nephrology in november 2011. this problem appears to have been growing virtually unnoticed for many years, but apparently with the increased market share of granuflo in the us and a lack of clinical knowledge about total buffer levels, more clinical problems have become evident.
granuflo formulations are unique in that they use sodium diacetate (note the “di”). what was virtually unnoticed by the prescribing physicians with the introduction of granuflo in 2003 is that it doubles the amount of acetate in dialysate compared to formulations made with acetic acid. instead of adding 4 meq/l of acetate, it adds 8meq/l. this means that for dialysates made from granuflo, the total buffer level is 8 meq/l higher than the bicarbonate level delivered from the bicarbonate concentrate.
lacking clinical knowledge, as well as a lack of effective product-related education from the manufacturer, often exacerbates this situation. if a physician orders a bicarbonate level of 37 meq/l for the patient, the clinic may set the dialysis machine to deliver 37 meq/l from the bicarbonate concentrate alone. if the clinic is using granuflo, the patient may receive a total buffer load of 45 meq/l instead of the 37 meq/l of bicarbonate normally prescribed by the physician. some clinics may have delivered, or may still be delivering, total buffer levels as high as 48 meq/l.
[color=#990000](additional information added may 21, 2:30 am edt: in my effort to simplify the chemistry involved, i added an error to the article.
sodium diacetate is made up of equal parts of acetic acid and sodium acetate. the acetic acid will become co2 (carbon dioxide)and water, not bicarbonate in the body. the sodium acetate can become sodium bicarbonate in the body.)
the fda’s role
dialysate concentrates are treated as medical devices by the fda, not as drugs, although they can dramatically alter patients’ electrolytes, bicarbonate level, and blood ph. when the granuflo product was submitted to the fda in 2003 (510k #k030497), it was described as equivalent to predicate products that were already on the market. sodium diacetate was considered equivalent to glacial acetic acid despite the fact that it had double the amount of acetate.
many medications and physiological processes function normally or optimally only when blood ph levels are maintained within a very narrow range.
part ii – what occurred within fmc… despite its patient safety organization?
i received copies of both the internal fmc memo and the fmc memo that was sent to non-fmc customers regarding this bicarbonate/alkalosis issue on saturday, may 12, 2012 . after comparing them for approximately one hour, i began contacting the executives of dialysis clinic corporations whose patients may have been at risk. these organizations then began obtaining their own copies of the internal fmc memo from fmc sources. i have not provided copies of the internal fmc memo to anyone. using this methodology, within a few days, action was taken to safeguard at least 2000 patients who were found to be at risk. i have also contacted the national renal adminstrators association and the renal physicians association and have urged them to employ the same method.
i have been in contact with the fda. they have replied that they are aware of the issue and will be providing appropriate information to the public shortly.
- May 31, '12 by anurseadvocatethe below is the fda's recall ----for those of you working at an fmc unit, or a unit that used this product ---here is the recall information -- i have heard that some units were not notified (non fmc units)....
fresenius medical naturalyte acid concentrate for bicarbonate dialysis 45x , 55 gallons (208.2 liters) cat. no. 13-2251-0. naturalyte liquid acid concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates. recall # z-1612-2012
lot 11ptac022. expiration date: 11/30/2013
recalling firm: fresenius medical care holdings, inc., waltham, ma, by letter dated march 28, 2012.
manufacturer: fresenius medical care north america, irving, tx. firm initiated recall is ongoing.
sodium content does not meet product requirements.
volume of product in commerce
154 drums (55gal/drum)
- Jun 11, '12 by RaydenTo those nurses working on units using Granuflo, what adjustments have been made on the default sodium and bicarbonate values on your machines?
- Jun 12, '12 by traumaRUsANURSEADVOCATE - as one of the mid-levels who works in several FMC HDUs - we were notified as soon as the problem was noted.
Rayden - in our practice, we adjust the Na and bicarb based on labs done at least monthly and sometimes twice/month.
- Jul 6, '12 by RaydenHere's an update.
FDA Places GranuFlo, NaturaLyte Under Serious Recall Category
- Jul 6, '12 by anurseadvocateI think part of the problem was that FMC did not notify other units (other than FMC) that they provided the granuflo for -- there are ongoing articles, etc on this and if I have permission I can post and/or direct
- Jul 7, '12 by zero.Upon discovery of this issue, I recommended to the higher ups that we shift to Rockwell's Citrapure.
We're expecting the change to be implemented in 2 months time as we are just consuming the rest of the Granuflo that we have. In the meantime, Na and HC03 adjustments were made individually according to each patient's pre-HD bicarb level, of which we assess every 2 weeks.
- Jul 8, '12 by anurseadvocateForgive me for asking, but I am a bit confused -- I was under the impression that ALL units using granuflo had to stop using the product immediately ?
- Jul 8, '12 by anurseadvocateWhen you say you are 'consuming the rest of the Granuflo that we have"... isn't this somewhat dangerous??