B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES has been recalled in what the U.S. Food and Drug Administration (FDA) is listing as a Class I Recall. According to the FDA, the hardware in the defective medical device may become unresponsive.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these recalled products will cause serious adverse health consequences or death.
The recalled medical devices were manufactured from May 21, 2009 to June 23, 2009 and distributed from July, 24, 2009 to December 31, 2009 and were upgraded from May 4, 2010 to June 21, 2010.
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 and that the recalled infusion system is defective.
The B. Braun Outlook 400ES Safety Infusion System is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.
The defective infusion system, when working properly, is capable of delivering fluid when the IV fluid container is lower than the pump and provides the accurate volume of all standard IV fluid, including blood, lipids, and Total Parenteral Nutrition (TPN).
The FDA indicates that customers should deactivate the wireless communication on their pumps and return them to the manufacturer. The recalling firm is B. Braun Medical, Inc.â€¨and is located at 1601 Wallace Drive Ste 150â€¨Carrollton, Texas 75006. The firm can be reached at: 1-972-245-2243.
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. Information on the Defective Infusion System should be submitted in one of the methods described below:
â€¢ Complete and submit the report online at: www.fda.gov/MedWatch/report.htm
â€¢ Download the form at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
â€¢ Call 1-800-332-1088 to request a reporting form
â€¢ Complete and return the form to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.