FDA links saline supply chain mixup to patient death

A Practi-100mL IV Solution Bag with sterile distilled water, which simulates sodium chloride--Courtesy of Wallcur

The saline shortage may have claimed a life. The FDA reported that one person has died and many more have taken ill after receiving simulated intravenous products that are intended for training use only.

San Diego, CA-based Wallcur manufactures the intravenous products as part of its range of training tools. Last year the products somehow entered the supply chain for genuine saline products, leading to a recall notice from Wallcur, a safety alert by FDA and other state-level warnings. The message arrived too late for some people, though. FDA reports more than 40 people have received the training product, one of whom has died. The regulator is yet to determine if the product caused the death.

The FDA is now working with distributors to figure out how the training products came to be shipped to surgical centers, medical clinics and emergency wards in 7 states. The shortage of genuine saline is one possible trigger for the situation. Baxter International ($BAX) and Hospira ($HSP) both initiated multiple recalls of saline last year, prompting the FDA to temporarily allow Fresenius Kabi to ship products from Norway. The FDA also cleared Baxter and B. Braun Medical to distribute saline.

The actions mean saline is now available from several manufacturers, according to the FDA, but supplies have been tight. What role--if any--this situation played in medical centers in Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado sourcing Wallcur products is currently unclear.

- read the FDA notice
- here's Reuters' take

Suggested Articles

McCallum was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.

The FDA made public a voluntary recall of sterile injectables made by Coastal Meds of Mississippi, after visible particles were found in some vials.

It’s been a strange road for BMS' Opdivo-Yervoy combo in first-line kidney cancer, but the New Jersey drugmaker finally has a go-ahead.