FDAnews
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FDA ISSUES RECALL ON GAMBRO RENAL DEVICE

March 3, 2006

The FDA has issued a Class I recall for Gambro Rena's Prisma continuous renal replacement system (CRRT), following a flurry of serious complaints associated with the device, including 11 injuries and nine deaths.

Critically ill patients receiving the therapy may suffer from excessive fluid loss if caregivers override the device's "incorrect weight change detected" alarm, the FDA said. The recall states that caregivers must never override this alarm without first identifying and removing the cause of it.

The recall follows a public health notice on the CRRT issued by the FDA Feb. 27.

The Gambro CRRT system is used in hospital intensive care units and other facilities for continuous solute and/or fluid removal in patients with acute renal failure. The system is a type of hemodialysis that removes, filters and returns the blood slowly and continuously in patients.