At least 40 patients were accidentally given injections of Wallcur Practi-0.9%, an intravenous (IV) solution of non-sterile water that is only intended for training purposes. One death has been reported. The products were recalled in January 2015.
UPDATE: IV Saline Illness Outbreak Sickens 17
January 16, 2015 — The CDC reports that 17 people were sickened out of 40 who received Practi-0.9% training IV solution by mistake. A shortage of medical-grade saline in the U.S. may be contributing to the problem, with clinics now being forced to import saline (salt water) across the ocean from Europe. Click here to read more.
What is Wallcur Practi-IV Solution?
Wallcur, LLC is a California-based company that makes training products for nurses, paramedics, pharmacists, EMT, and other healthcare professionals.
Practi-0.9% Sodium Chloride simulates intravenous (IV) injection of saline solution. However, instead of saline, it contains distilled water that is not sterile and is only intended for use on a mannikin.
What is the problem?
In January 2015, the FDA reported that Wallcur IV training solution was mistakenly injected in at least 40 people. Many of them rapidly developed adverse reactions. One person died, although it it not clear whether the death was caused by the IV solution.
According to the FDA Safety Investigation:
“Patients who received simulated IV saline almost immediately upon injection experienced fever, chills, tremors, muscle aches, headaches, and some required hospitalization.”
The following seven states have reported adverse events: Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado.
Wallcur IV Solution Recall
On January 7, 2015, Wallcur issued a recall for the following products:
- Wallcur Practi-0.9% sodium chloride IV bags supplied in 50 mL, 250 mL, 500 mL, and 1000 mL sizes
- Wallcur Practi-0.9% sodium chloride 100mL IV solution bag sterile distilled water.
The products have been shipped since May 22, 2014 to medical clinics, surgical centers, and urgent care facilities all over the United States.
Wallcur will correct the problem by adding more prominent warning labels that the products are not intended for use in humans or animals.
Side Effects
- Fever
- Chills
- Tremors
- Muscle aches
- Headaches
- Hospitalization
- Death
Complications
Saline solution is most often given to patients who are dehydrated, have electrolyte imbalances, need a blood transfusion, or delivery of a medication. Patients who are injected with non-sterile water instead of saline could develop a bloodstream infection. Patients with electrolyte imbalances are at risk of deadly neurological and cardiovascular complications.
What Should I Do?
Healthcare professionals should visually inspect all current IV saline solution bags. Products that are marked with “Wallcur,” “Practi-products,” “For clinical simulation,” or “Not for use in human or animal patients” should not be administered to patients.
If you have these products, quarantine them and contact Wellcor for return instructions. The FDA is temporarily allowing imports of saline solution from European drug-makers to deal with a shortage in the United States.
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