Class I Medical Device Recall: B. Braun, Outlook 400ES Safety Infusion System, Model Number 621-400ES
Recall Class: Class I
Date Recall Initiated: August 24, 2010
Outlook 400ES Safety Infusion System
Model number 621-400ES
Manufacturing From: May 21, 2009 - June 23, 2009
Distribution From: July, 24, 2009 - December 31, 2009
The recalled products were upgraded from May 4, 2010 - June 21, 2010.
Use: 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).
B. Braun Medical, Inc.
1601 Wallace Dr. Ste 150
Carrollton, Texas 75006
Reason for Recall: 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.
Public Contact: Questions should be directed to B. Braun at 972-245-2243.
FDA District: Dallas
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.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experience using these products to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.