The U.S. Food and Drug Administration said on Wednesday, Jan. 14, that at least 40 people were administered intravenous fluids meant for training purposes only, causing many to get sick and one to die.
The news comes less than a month after the agency advised doctors not to give patients simulated intravenous products manufactured by Wallcur, a provider of medical training products.
According to the FDA, patients were accidentally given simulated saline solutions that were shipped to urgent care facilities, surgical centers and medical clinics across seven states. Adverse reactions reported include headaches, tremors, chills and fevers, with some patients requiring hospitalization. The death associated with the incident is still being investigated to determine if the accidental administration of the simulated saline solution was the real cause.
Working with the Centers for Disease Control and Prevention (CDC), the FDA collected Wallcur Practi 0.9% Sodium Chloride samples from distributors and clinics. The samples are undergoing tests to determine if they caused the adverse reactions in patients.
Wallcur had initiated a voluntary recall of the IV solutions in question. States affected include Colorado, New York, North Carolina, Louisiana, Idaho, Georgia and Florida.
"Despite the fact that the products are intended 'for clinical simulation' only, we are aware of reports that these products have been used outside of their intended use and administered to patients," said Wallcur in a statement.
Many of the medical facilities affected said they were not aware that the saline solutions were simulated products. At least one did recognize the Wallcur product they were given was for simulation purposes, promptly returning the product to the distributor.
The FDA is also working with distributors to determine how the simulation products were able to penetrate the supply chain and were eventually given to patients.
Normal saline solutions have been in tight supply since last year so the FDA has allowed the temporary distribution of intravenous products from alternate sources. At the moment, IV products come from B. Braun Medical Inc., Baxter Healthcare Corp., and Fresenius Kabi USA.
Healthcare providers are advised to visually inspect all saline solution bags currently in their inventory to ensure none are labeled "Practi-products," "Not for use in human or animal patients," or "For clinical simulation."
All saline products for training purposes received by mistake must be separated and returned. To ensure all IV products are for clinical use, office procedures must also be reviewed to guarantee visual inspections are in place.