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FDA and Gambro Renal Products Issue Warning Regarding Injuries and Deaths Caused by Misuse of Prisma Renal Replacement System

Aug 21, 2005 | In a worldwide safety alert issued jointly by the FDA and Gambro Dasco S.p.A. (Gambro) , a production unit of Gambro Renal Products, healthcare professionals were warned that there have been a number of serious injuries and deaths as a result of the misuse of the company’s Prisma® continuous renal replacement system (all catalog numbers).

The devices are used in intensive-care situations where patients are suffering from kidney failure.

Gambro maintains that these injuries and deaths were not caused by any defect or problem with the product itself. Rather, the company insists that some users of these medical devices have been overriding alarms on the machine that specifically warn of fluid imbalances.

As a result, healthcare professionals have been alerted that they must pay particular attention to the "Incorrect Weight Change Detected" alarm. This alarm should never be overridden without first identifying and removing the cause of the alarm.

The injuries and deaths are the result of excessive ultrafiltration (fluid being removed from the patient's body). This problem can occur when the user does not immediately address the cause of the "Incorrect Weight Change Detected" alarm.

According to Gambro, the device itself “remains appropriate for use” as long as the alarm-related instructions are properly followed.

Two people in the U.S. died in January and the company is reviewing adverse event reports, along with the FDA, in order to determine the number of injuries involved.
The press release noted that in addition to the Safety Alert, Gambro will initiate an Advisory Notice and Field Corrective Action in the immediate future. This Action will include updated Prisma System Operator's Manuals with an additional warning; a label for customers to place on machines; and enhanced training specifically addressing the "Incorrect Weight Change Detected" alarm.

The company states it is imperative that users follow the manufacturer's Instructions For Use, Operator's Manual, and the User Interface of the Prisma System.

Customers in the U.S. with questions or concerns about the Prisma System or this Safety Alert, should contact Gambro Renal Products, Inc., Intensive Care Therapy Specialists at 1-800-525-2623. For customers outside the U.S., contact your local country manager or sales representative.

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