FDA Recalls B. Braun and Alaris Infusion Systems Infusion PumpsAugust 06, 2012
The US Food and Drug Administration (FDA) recently issued a Class I Recall for two infusion pump systems, namely the B. Braun Infusomat Space Infusion System and the CareFusion Alaris PC Unit, Model 8015.
The FDA notified healthcare systems and professionals of the Class I Recall for the B. Braun Infusomat Space Infusion System due to a potential breakage of the anti-free flow chip catch in the infusion pump door. According to the agency, the chip may break when improperly inserted and the pump door is forced closed. When this happens, free flow may happen and can cause fatal injury.
The CareFusion Alaris PC Unit, Model 8015 may generate a (120.4630) “System Error” or “Missing Battery Error” due to a component in the PC unit power supply. The FDA said that ifthe error code occurs during start up, the Alaris infusion pump may not be programmed, thus delaying patient medication therapy. The delay with the programming may have life-threatening effects to the patient.
Both pump systems are used for intravenous (IV) fluid and medication infusions. Models due for recall are the CareFusion Alaris PC Model 8015 units and B. Braun Infusomat Space Infusion System pumps. Full details for each recall can be found on the FDA website visit the links below.
AIV supports replacement parts and services for Alaris, B. Braun infusion and other leading infusion pumps in the market. Browse through AIV’s full line of products and repair services for these infusion pumps at http://www.aiv-inc.com/iv-infusion-pump-replacement-parts.html.
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