FDA NOTIFICATION RELEASED FOR GAMBRO RENAL PRODUCT
The FDA has issued an updated public health notification on the Gambro Prisma Continuous Renal Replacement System that includes information about a risk of death.
The agency emphasized to renal dialysis caregivers that "special caution must be used" when operating the system to prevent excessive fluid removal from patients. It said that caregivers must pay particular attention to the "Incorrect Weight Change Detected" alarms, which are designed to alert the user of a potential fluid imbalance occurring during the course of therapy. If treatment continues without resolving the cause of these alarms, "excessive fluid may be removed from the patient, and this can result in serious injury or death," the FDA said.
The three-page warning notification from Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, stated that the FDA has become aware of "additional serious injuries and deaths" associated with the use of the device since the release of the preliminary public health notification in August 2005.
The Gambro system is a type of kidney dialysis system used in hospital intensive care units and other facilities for critically ill patients.
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