Gambro Prismaflex CRRT

7-Apr-2011
The touchscreen interface used in the Gambro Prismaflex continuous renal replacement therapy (CRRT) system may occasionally become unresponsive. Gambro has developed software that addresses the problem; the software has not yet been released in the United States. Until that software is available, facilities should develop an action plan for users to follow if the problem occurs.

The U.S. Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database includes several reports from within the last year that describe similar events.

Gambro is aware that the Prismaflex touchscreen interface may become unresponsive and believes that the problem occurs when clinicians press softkeys in very rapid succession, such as when navigating quickly through alarm screens. The company indicates that it has received no reports of injury related to the problem and believes that it does not present a safety risk. Nonetheless, Gambro indicates that it has addressed (or plans to address) the issue in software revisions.

Gambro states that outside the United States, the baseline software version (4.10) is not affected by the problem. Within the United States, the company anticipates addressing the issue with the release of version 5.10, which will replace the version currently in use (3.2) and will be available free of charge. Gambro expects FDA 510(k) clearance for version 5.10 in the near future.

Source: ECRI Institute

1 comment:

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