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BY OUR PHARMA CORRESPONDENT
20th August, 2005: Gambro Dasco SpA, has issued a worldwide safety alert for the Prisma renal replacement system.
The alert is binding for all catalogue numbers. A production unit within Gambro Renal Products, Gambro Dasco has become aware of several serious injuries and deaths relating to the use of its Prisma System. As a result, caregivers must pay particular attention to the "Incorrect Weight Change Detected" alarm, the company announced in a press communique.
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 address the cause of the "Incorrect Weight Change Detected" alarm. The device remains appropriate for use when these directions are followed, the release stated.
As a follow-up to this 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.
It is imperative that users follow the manufacturer's Instructions For Use, Operator's Manual, and the User Interface of the Prisma System, the release added.
BY OUR PHARMA CORRESPONDENT
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