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U.S. Department of Health and Human Services

Safety

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Prisma Continuous Renal Replacement System

Audience: Nephrologists, other healthcare professionals and consumers

[UPDATE Posted 03/01/2006] The August 2005 Preliminary Public Health Notification was updated with additional safety information.

[Posted 08/19/2005] Gambro Dasco S.p.A notified healthcare professionals and consumers of a safety alert for the Prisma continuous renal replacement system (all catalog numbers). Gambro Dasco has become aware of several serious injuries and deaths resulting from excessive ultrafiltration (fluid being removed from the patient’s body). This problem can occur when the user does not address the cause of the “Incorrect Weight Change Detected” alarm. This alarm should never be overridden without first identifying and removing the cause of the alarm. The device remains appropriate for use when these directions are followed.

[February 27, 2006 - FDA Updated Public Health Notification - FDA]
[August 23, 2005 - Preliminary Public Health Notification - FDA]
[August 16, 2005 - Press Release - Gambro Dasco S.p.A.]