ALERT: Nonsterile IV saline sent to facilities

[nurseprnRN, BSN, RN]

The US Food and Drug Administration (FDA) is warning that Wallcur's simulated IV saline solution, Practi-0.9% sodium chloride solution, has been inappropriately sent to medical clinics, surgical centers, and urgent care facilities in several states.

The solution is meant for training purposes only and should not be used in patients, the agency emphasizes in the new drug safety communication.

The FDA, together with the Centers for Disease Control and Prevention, have identified more than 40 patients who have been injected with the solutions, which are not sterile and not meant for either patient or animal use.

Adverse events associated with the injections have been reported in seven states: Colorado, Florida, Georgia, Idaho, Louisiana, New York, and North Carolina. Reported events include fever, chills, tremors, and headache. Some patients have required hospitalization and one patient has died. The agency says testing is on-going to determine if the death was directly related to the product.

The agency first warned of the use of the simulated IV solutions in patients on December 30, 2014. The company issued a voluntary recall of the related products on January 7. However, the agency notes that most medical facilities have said they were unaware that the IV products they received were simulation products; only one clinic recognized the problem and returned the solutions.

The agency now recommends that clinicians and office staff inspect all IV saline solution bags currently in stock. Any bags labeled with any of these phrases — "Wallcur," "Practi-products," "For clinical simulation," or "Not for use in human or animal patients" — should be returned to the distributor.

More information on today's announcement is available on the FDA website. FDA's investigation into patients being injected with simulated IV fluids continues

[mrsboots87]

So if I am reading this correctly, the bags that were sent to the facility were marked all over with words and phrases to identify the product as a practice solution. Multiple health professionals missed this. From whoever receives, to those who scan and stock the med rooms, to the nurse or whoever hanging the bag, to the multiple people who check on a patient and should be checking the bags. And now multiple patients across a few states were infused with the practice product that has caused adverse reactions in some. This overall is just terrible and how did so many people miss this mistake before it reached patients? I am only a student and do not pretend that I will never make a mistake. I even understand that this could have been me if I were already a nurse, though I certainly would hope I don't let stress keep me from doing a proper med check before hanging a bag of fluid. But dang is this just a really bad error made by quite a few people. I will have to keep this in the back of my mind as a reminder of why checking all meds and fluids is sooooo important.

[toomuchbaloney]

Recently an instructor at University of Alaska Fairbanks who is a BSN RN nearly done with her Masters level education, provided her Medical Assistant students with a similar "practice" liquid in vials and required them to draw up and inject one another with it as practice for their skill set. The entire fiasco was publicized when one of the MA students contacted the manufacturer because the instructor was NOT responsive to the alert and competent review of the vial by the student.

These type of errors are completely avoidable and preventable. I believe that instructor in the above case should have lost her job but I am not certain that she did.

[dudette10, MSN, RN]

So if I am reading this correctly, the bags that were sent to the facility were marked all over with words and phrases to identify the product as a practice solution. Multiple health professionals missed this. From whoever receives, to those who scan and stock the med rooms, to the nurse or whoever hanging the bag, to the multiple people who check on a patient and should be checking the bags. And now multiple patients across a few states were infused with the practice product that has caused adverse reactions in some. This overall is just terrible and how did so many people miss this mistake before it reached patients? I am only a student and do not pretend that I will never make a mistake. I even understand that this could have been me if I were already a nurse, though I certainly would hope I don't let stress keep me from doing a proper med check before hanging a bag of fluid. But dang is this just a really bad error made by quite a few people. I will have to keep this in the back of my mind as a reminder of why checking all meds and fluids is sooooo important.

On the link, there is a picture of a bag of the simulated product. Take a look and tell me if you would have noticed the warnings.

[dudette10, MSN, RN]

I found a link to more pictures. PHOTO Wallcur Practi-0.9% Sodium Chloride-IV Bags 50 mL, 250 mL, 500, mL, and 1000 mL Wallcur Practi-0.9% Sodium Chloride-IV Bag with Distilled Water 100 mL

[nrsang97, BSN, RN]

I found a link to more pictures. PHOTO Wallcur Practi-0.9% Sodium Chloride-IV Bags 50 mL, 250 mL, 500, mL, and 1000 mL Wallcur Practi-0.9% Sodium Chloride-IV Bag with Distilled Water 100 mL

I can see nowhere that says that those aren't used for human or animal infusion. That is scary. I would have probably thought it was a new brand name. Crazy. I wouldn't have figured that practi meant practice.

[Christy1019, ASN, RN]

^^^ This! The bags we used in nursing school were normal saline bags that were just refilled with water or whatever, I never even thought about there being fake solutions for practice. And I'm sure the nurses will somehow be blamed for these med errors because we are ultimately responsible for the "last check", ugh.

[icuRNmaggie, BSN, RN]

If these bags were stocked in a pyxis accudose or an open bin as 0.9 sodium chloride I could have easily made the same mistake, if I was in a big hurry, as I have never heard of wallcur practidose. Thank you for the heads up.

[kbrn2002, ADN, RN]

I don't deal with a lot of IV fluids where I work, but I gotta say I don't think I would've caught that. Looking at the pictures of the product, I am pretty positive that without this heads up I would just assume that "Practi" on the label was part of the brand name. If there are any other warnings on that bag they were way too small to read in the pictures provided.

[LadyFree28, BSN, LPN, RN]

On the link, there is a picture of a bag of the simulated product. Take a look and tell me if you would have noticed the warnings.

For the new nurse, or even the experienced nurse, maybe not; but I will Google the product, then will call supply and or the pharmacy and ask if this was a new product before I hung the bag...I would be apprehensive to hang something with "practi-" before a fluid.

[blondy2061h, MSN, RN]

The bags were used in nursing school were dyed blue! This was posted on my work's internal website like 2 weeks ago when it first happened. I read the notice thinking "How the heck does that happen?!?!" Then I saw the picture. Scary!

[blondy2061h, MSN, RN]

Recently an instructor at University of Alaska Fairbanks who is a BSN RN nearly done with her Masters level education, provided her Medical Assistant students with a similar "practice" liquid in vials and required them to draw up and inject one another with it as practice for their skill set. The entire fiasco was publicized when one of the MA students contacted the manufacturer because the instructor was NOT responsive to the alert and competent review of the vial by the student.

These type of errors are completely avoidable and preventable. I believe that instructor in the above case should have lost her job but I am not certain that she did.

At least an injection is only like 1-2 ml's. People were being intravenously infused with a whole liter of this. The sodium problems alone (since it was actually water).