B. Braun Infusomat Space Infusion System: Class I Recall - Potential for Breakage of Anti Free Flow Clip Catch

AUDIENCE: Risk Manager

ISSUE: FDA Notified healthcare professionals of a Class I Recall of the B. Braun Infusomat Space Infusion System, due to the potential for breakage of the anti free flow clip catch located inside the infusion pump door. Breakage may occur when the IV set anti free flow clip catch is inserted improperly into the pump and the pump door is forced closed. Misloading of the anti free flow clip catch may create the potential for free flow of medication. Free flow, especially of narrow therapeutic range drugs, can cause life-threatening effects and injuries.

Affected pumps were distributed from November 6, 2008, to December 29, 2011. See the Recall Notice for a list of affected model numbers.

BACKGROUND: The Infusomat is an infusion pump system used to provide intravenous (IV) infusions of fluids, medications, blood, and blood products to adult, pediatric, and neonatal patients. This device is used in hospitals.

RECOMMENDATIONS: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm¹
• Download form² or call 1-800-332-1088, FREE 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178