B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall - Hardware May Become Unresponsive
MedSun: Newsletter #58, March 2011

FDA MedWatch Safety Alert

Infusion systems upgraded with the Motorola compact flash hardware and supporting software, when used in a network environment that utilizes Temporal Key Integrity Protocol (TKIP) authentication, can potentially induce a memory leak that can cause the Management Processor to become non-responsive. This causes normal operation to stop, which is signaled by an audible backup alarm indicating that the pump is not delivering the medicine. There is no visual error warning to alert the user that the pump is not working. Customers should deactivate the wireless communication on their pumps and return them to the manufacturer.

Additional Information:

FDA MedWatch Safety Alert. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall - Hardware May Become Unresponsive. February 1, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm241637.htm


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