The infusion system, B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES, has been recalled in a U.S. Food and Drug Administration Class I Recall.
The FDA claims the hardware in the defective medical device may become unresponsive, and can potentially cause the Management Processor to become non-responsive, which then causes normal operation to stop. Although an audible alarm lets medical staff that know the pump is not delivering medicine, no visual warning accompanies the alert.
The FDA regards Class 1 recalls as the most serious type, involving a reasonable probability that use of these recalled products will cause serious adverse health consequences or death. The 400ES devices were manufactured from May 21, 2009 to June 23, 2009 and distributed from July, 24, 2009 to December 31, 2009.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these Recalled Medical Devices to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm.
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