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.
The manufacturer shouldn't have tried to make the label look like the what is currently being used in hospitals, because it does look similar to a common label of normal saline that I'm used to seeing. I'm shocked that it was overlooked by so many people. Students in nursing school don't need IV fluids that are so realistic that even the labeling looks real.
Extra scary because this comes in the middle of a shortage of sterile 0.9% NaCl - per the FDA shortages website there are 5 manufacturers that have been on shortages of some kind since 03/2014 with 0.9% NaCl. We've changed suppliers multiple times in the last year (generally we get whatever is available).
This is a total cluster! These bags are WAY too similar to the real deal to be distributed for any kind of use. One bag is labeled Practi 0.9% Sodium Chloride then states Contents: Sterile Distilled Water. The only clear danger sign is "Product of China"
Makes me think again about how much our patients trust us to be doing the right thing. We have an incredible amount of responsibility that we should never take lightly. Note to self: NEVER forget this.
..... and now back to our regularly scheduled programming of being the best damn nurses we can be!
Would you have taken all that time to double check the bag of fluids in a code or emergency? Just curious. I think this was a systematic failure . Even the brightest nurse just as yourself could have missed this.
Specializes in Case mgmt., rehab, (CRRN), LTC & psych.
Let me guess....so many facilities in multiple states ordered this stuff because perhaps it was substantially cheaper than the normal saline they usually purchase?
The urge to save a few bucks can be the root of all evil.
Would you have taken all that time to double check the bag of fluids in a code or emergency? Just curious. I think this was a systematic failure . Even the brightest nurse just as yourself could have missed this.
As someone who has worked in a setting such as the PICU, yes, I did double check on bags of fluids to make sure it was the correct one; with children in certain emergencies, one doesn't want a complication such as fluid overload to complicate things.
Thank you, mods, for editing my post to add the ALERT and include more updated information on states where patients were affected. This is an ongoing situation.
Mulan
2,228 Posts
Does it say PRODUCT OF CHINA on it?
That would scare me right there.