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| Wallcur IV bag--Courtesy of Wallcur |
The FDA and the Centers for Disease Control and Prevention (CDC) are investigating the possible death of one patient and illnesses in more than a dozen others across 7 states after several hundred bags of IV solution meant for training healthcare workers ended up being used on more than 40 patients.
Wallcur, the San Diego-based maker of medical training products, recalled the bags, which it said were marked "for clinical simulation" last week. They were shipped to medical clinics, surgery centers and urgent care facilities last summer, and were supposed to be used only for training purposes and not on humans or animals because the IV solution isn't sterile.
According to The New York Times, a hospice patient died after being treated with the solution, although health officials could not say the saline solution was the cause. Others reported symptoms that included chills, fever, tremors and headaches after being given the solution.
Paul Delmore, an attorney for Wallcur, which specializes in medical education and training products, told the Times the company only sells to clients like nursing schools, and not to hospitals or clinics. Delmore, added that Wallcur does sell to other distribution companies, and all of the reported symptoms were linked to shipments from one of those distributors.
The FDA is working with distributors to see how the practice saline solution was able to penetrate the supply chain and be given to patients. So far, the states where it was distributed are Colorado, New York, North Carolina, Louisiana, Idaho, Georgia and Florida.
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. Currently, IV products come from B. Braun Medical, Baxter ($BAX), and Fresenius Kabi USA.
- see the FDA warning release
- read the NYT story (sub. req.)