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Infusion Pump System Recalled For Faulty Part Possibly Causing Life-Threatening Injuries


The B. Braun Infusomat Space Infusion System is subject to a Class I recall 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.

 

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. Affected pumps were distributed from November 6, 2008, to December 29, 2011.

 

All Infusomats on the market, including 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.

 

Customers using pumps with software versions G02 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.

 

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

 

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