Company: B. Braun Medical, Inc..
Date of Enforcement Report 8/24/10
Class l:
PRODUCT
Outlook 400ES Safety Infusion System
Model number 621-400ES
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 infusion system 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).
REASON
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.
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Carrollton, Texas
FDA Comments: On August 24, 2010, the firm notified its customers, by mail, about the problem. In the letter, the firm directed its customers to deactivate the wireless communication on their pumps and return them to the manufacturer.
FDA District: Dallas
DISTRIBUTION
Nationwide
