Gambro Dasco S.p.A., a production unit of Gambro Renal Products, issued a worldwide Safety Alert for its Prisma continuous renal replacement system. The Prisma system is used in intensive care units to filtrate the blood of dialysis patients in intensive care. Gambro has been notified of several serious injuries and deaths due to misuse of the devices.

Problems with the Prisma are related to an “Incorrect Weight Change Detected” alarm. If the user of the device does not address the cause of the alarm before overriding it, too much fluid can be removed from the patient’s body. Gambro will updated the operating manuals of the Prisma system, install labels on existing machines and enhance training to address the “Incorrect Weight Change Detected” alarm.

Misuse of medical devices may be an indication of medical malpractice. Customers concerned about the safety of the Prisma system can contact Gambro toll-free at 1-800-525-2623.

Source: Gambro Press Release, August 16, 2005.