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:
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:
[08/01/2012 - Recall Notice - FDA]