B. Braun Infusomat Space Infusion System Recalled due to Potential for Breakage of Anti Free Flow Clip Catch that can be Life-Threatening

The FDA notifies Risk Managers and healthcare personnel that B. Braun Infusomat Space Infusion System is recalled because, due to the potential for breakage of a component in the infusion pump door, the possibility of free flow of medication may cause life-threatening injuries.

Background of B. Braun Infusomat Space Infusion System

Infusomat Space Infusion System, by B. Braun Medical Inc., is used in hospitals for the provision of intravenous infusions of various medications and fluids from neonatal to adult patients. FDA Alert on B. Braun Infusomat Space Infusion System

This recall in an expansion of the prenious one in January, 2012 because of the potential breakage of the anti free flow clip catch in the infusion pump door. This can cause the free flow of medication and it may lead to serious injury, including death particularly in cases of narrow therapeutic range drugs.

The affected Infusomat Space Infusion System models are:  8713050U, 8713050U-99, 8713050US, 8713060U, and 8713060U-99 with software versions G03, G02, or older.

The affected product’s distribution dates were from November 6, 2008, to December 29, 2011.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on B. Braun Infusomat Space Infusion System

“B. Braun is contacting customers to make arrangements to have the metal clip catch added to all pumps, as well as modifying door jambs on certain models:

• All Infusomats on the market, which includes pumps with software versions G03, G02, or older, are being upgraded with a metal clip catch. This new material strengthens the clip catch and eliminates the potential for breakage of the current clip catch which is made of plastic.
• The door jamb on pumps with G03 software will be removed from the pump. The original intent of the door jamb was to minimize potential for breakage. However, it does not eliminate breakage when high forces are applied.
• Inclusion of pumps with software versions G02 or earlier. These customers were reminded about the importance of following the instructions for use to avoid potential IV set misloading. Customers were provided with information about the potential risks that may occur when instructions for use are not followed and the IV set is misloaded.”

Contacting the FDA to report cases with B. Braun Infusomat Space Infusion System

In case of detection of adverse events or side effects related to the use of B. Braun Infusomat Space Infusion System, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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