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Safety Alert Issued For Continuous Renal Replacement System

Aug 19, 2005 | www.medpagetoaday.com

The maker of a total renal replacement system has alerted doctors that failure to carefully follow its instructions when responding to the machine's alarm system has caused injury and death to patients.

Gambro Renal Products has issued a worldwide safety alert for its Prisma continuous renal replacement system. The alert, which covers all Prisma catalogue numbers, was issued by Gambro Dasco S.p.A., a production unit of Gambro located here.

In a statement, the company said it "has become aware of several serious injuries and deaths related to the use of its Prisma system."

The company statement indicated that there are problems with the system's "Incorrect Weight Change Detected" alarm. "This alarm should never be overridden without first identifying and removing the cause of the alarm," the statement warned.

The injuries and deaths, according to the company, were associated with manual overrides of this alarm system, which cause "excessive ultrafiltration."

The company maintained that the device "remains appropriate for use" as long as directions for responding to the "Incorrect Weight Change Detected" alarm are followed.

"Gambro's top priority is the health and safety of the patients we serve," said company president Nick Mendez. "We take very seriously any situation that may be linked to our products in any way." He said the company issued the safety alert as part of its cooperation with the FDA.

In addition to the safety alert, Gambro plans to issue an advisory notice and "field corrective action." This will include distribution of an updated Prisma System Operator's Manual plus an additional warning label to be placed on the machines. The label will spell out procedures for handling the "Incorrect Weight Change Detected" alarm.


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