Outlook 400ES Safety Infusion Sys Cl l B. Braun

Company: B. Braun Medical, Inc
Date of Enforcement Report 1/24/2010
Class l:

PRODUCT
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).

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
B. Braun Medical, Inc., Carrollton, Texas

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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