(Reuters) - The U.S. Food and Drug Administration said on Wednesday that many people have been sickened and one has died after receiving intravenous fluids that were meant to be used for training purposes only.
News of the death comes less than a month after the FDA told physicians not to use simulated intravenous products made by Wallcur LLC, a private company based in San Diego, California that makes products for medical training.
The FDA said at the time that there had been reports of serious adverse events associated with use of some of Wallcur’s products.
In its latest announcement the agency provided further details, saying more than 40 patients have received infusions of simulated saline solution, which was shipped to medical clinics, surgical centers and urgent care facilities in seven states.
The FDA said many patients have experienced adverse effects, including fever, chills, tremors and headache. Some have been hospitalized and one has died. The agency said it does not know whether the death was directly related to the product.
The FDA, together with the Centers for Disease Control and Prevention, have collected samples of Wallcur’s Practi-0.9 percent sodium chloride IV solutions. Medical facilities have reported that they were unaware that the products were for simulation only.
The agency said it is working with distributors and clinics to ascertain how the products entered the supply chain.
Medical-grade versions of 0.9 percent sodium chloride, also known as normal saline, have been in short supply. The drug is widely used to treat patients with dehydration and other medical conditions.
Last year the FDA said it would temporarily allow Fresenius Kabi USA LLC to distribute normal saline from its manufacturing facility in Norway. The agency said it is not objecting to the temporary distribution of additional normal saline from other sources, including Baxter Healthcare Corp and B. Braun Medical Inc.
The states affected by the recall are: Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado.
Reporting by Toni Clarke in Washington; editing by Andrew Hay