B. Braun Outlook 400ES Infusion System Recall Issued

B. Braun’s Outlook 400ES Safety Infusion System is being pulled from the market due to communication issues that may cause the system to unexpectedly stop delivering intravenous fluids to patients. 

The FDA announced the B. Braun Outlook infusion system recall on February 2, after the company received reports that the system was shutting down with no visual error warning. The FDA has categorized the market withdrawal as a Class I medical device recall, meaning that the agency believes that the defective devices has a potential to cause serious injury or death.

The Outlook 400ES is designed for use with the B. Braun Medical Inc. Horizon Pump IV Sets. The system regulates the flow of primary and secondary fluids when positive pressure is needed and is used to pump blood, lipids, Total Parenteral Nutrition and other standard IV fluids.

According to the FDA, the systems that were upgraded with a Motorola compact flash hardware and the supporting hardware can suffer a memory leak when used with a Temporal Key Integrity Protocol (TKIP) authentication. This can cause the system’s management processor to become non-responsive, causing the device to stop working. There is an audible alarm when this occurs, but there is no visual error warning.

The recall affects the Outlook 400ES Safety Infusion Systems with a model number of 621-400ES. The recalled systems were manufactured between May 21, 2009 and June 23, 2009 and distributed from July 24, 2009 through December 31, 2009. They were upgraded from May 4, 2010 through June 21, 2010.

B. Braun has recommended that customers deactivate the wireless communication on the pumps and return them to the manufacturer. Customers with questions can call B. Braun at 972-245-2243.

Last year, the FDA announced a new initiative to address safety problems with infusion pumps, which have been linked to more than 56,000 adverse event reports over the past five years, including at least 500 deaths. According to FDA data, there were 87 infusion pump recalls between 2005 and 2009 to address identified safety concerns.