FDA: B. Braun Safety Infusion System Recalled
Unresponsive management processor can cause infusion system to stop working
TUESDAY, Feb. 1 (HealthDay News) -- The U.S. Food and Drug Administration and B. Braun have notified health care providers and consumers of a class 1 recall of the B. Braun Outlook 400ES Safety Infusion System upgraded with the Motorola compact flash hardware and supporting software. The recall was issued because, when the system is used in a network environment that utilizes temporal key integrity protocol authentication, it can potentially induce a memory leak that may cause the management processor to become non-responsive.
The B. Braun Outlook 400ES Safety Infusion System is intended to be used with B. Braun Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.
The recall was issued because, when the management processor becomes non-responsive, operation of the infusion system stops. While an audible backup alarm will signal that the pump is not working, there is no visual error warning alert to notify the user the pump is not delivering medicine. On Aug. 24, 2010, B. Braun notified its customers in a letter, by mail, about the issue.
According to the FDA, "customers should deactivate the wireless communication on their pumps and return them to the manufacturer."