FDA Warns Healthcare Providers of Practice Saline Administered to Patients
Non-sterile saline solution meant only for training purposes and not use in humans has found its way to healthcare facilities and been incorrectly administered to patients in at least seven states, where it’s been linked to at least one death and has prompted the FDA to urge clinics, hospitals and other healthcare providers to check their saline stock.
More than 40 patients have been known to have been administered Practi-0.9% sodium chloride solution, a simulated IV saline solution manufactured by San Diego-based Wallcur. Many adverse events have been linked with administration of the practice solution, including fever, chills, tremors, headache and at least one death, although it’s unknown if that death is directly related to the saline, the FDA said in a safety alert.
The adverse events have been reported in Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado, according to the FDA.
Wallcur has initiated a voluntary recall of its saline and the FDA is urging clinicians and staff to check any products for labels that say “Wallcur,” “Practi-products,” “For clinical simulation,” or “Not for use in human or animal patients,” according to the alert. Wholesalers, distributors and suppliers are also asked to check their stock.
It’s unclear how the practice solution was shipped to healthcare facilities. The FDA said that it is currently investigating.
Healthcare providers have struggled recently with an ongoing shortage of saline. The FDA has been working with manufacturers to increase supply, the agency said. Wallcur did not respond to a request for additional comment by press time.
See the FDA warning notice here: www.fdanews.com/01-15-2015-Saline-Safety-Warning.pdf. – Bryan Koenig