Wallcur has recalled Practi-0.9% IV Solution, a non-sterile product intended for training purposes only, because it was mistakenly injected in at least 40 people.
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.
Overview
Wallcur, LLC is a San Diego-based manufacturer of intravenous (IV) training products for nurses, pharmacists, EMT, and other health professionals. They make Practi-0.9% Sodium Chloride, a bag of non-sterile distilled water that is intended to be used on mannikins.
40 People Injected With Non-Sterile IV Solution
The FDA has warned that 40 people were injected with non-sterile Wallcur IV training solution, including one person who died. The FDA is not sure if the death was caused by the solution.
Unfortunately, many serious adverse events have been reported:
“Patients who received simulated IV saline almost immediately upon injection experienced fever, chills, tremors, muscle aches, headaches, and some required hospitalization.”
Adverse events were reported in seven states: Florida, Georgia, Idaho, Louisiana, North Carolina, New York, and Colorado.
Wallcur Recalls Practi-0.9% IV Solution
A recall for Wallcur IV training solution was issued on January 7, one month after the FDA began investigating misuse of the product.
The recalled products include:
- Wallcur’s Practi-0.9% sodium chloride IV bags supplied in 50 mL, 250 mL, 500 mL, and 1000 mL sizes
- Practi-0.9% sodium chloride 100mL IV solution bag sterile distilled water.
Wallcur began shipping the products on May 22, 2014, to medical clinics, surgical centers, and urgent care facilities in several states.
Side Effects & Complications
Saline solution is primarily injected in patients who need treatment for dehydration, electrolyte imbalances, blood transfusions, or delivery of medications. If these patients are injected with non-sterile water, they can rapidly develop severe side effects.
For example, a patient with an electrolyte imbalance could have problems maintaining homeostasis in the body, resulting in life-threatening cardiovascular and neurological complications.
Another possible complication is a bloodstream infection from microbes in a contaminated solution.
Adverse reactions reported by the FDA include:
- Fever
- Chills
- Tremors
- Muscle aches
- Headaches
- Hospitalization
- Death
Recommendation
There is a shortage of medical-grade saline solution in the United States. Until manufacturers increase supply, the FDA is temporarily allowing imports from drug-makers in Europe.
Healthcare professionals should visually inspect all current IV saline solution bags. Do not use any products marked with “Wallcur,” “Practi-products,” “For clinical simulation,” or “Not for use in human or animal patients.”
If you have any of these products, quarantine them from products intended for clinical use. Contact the distributor, or Wallcur, LLC, for instructions on how to return the products.
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