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Infusion Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat Space Infusion System/ Large Volume Pump, Infusomat Space Large Volume Pump, Wireless, and lnfusomat Space Large Volume Pump, Non-Wireless BATTERY PACK Due to Faulty Occlusion Alarm
B. Braun Medical Inc. is expanding an earlier recall to add lnfusomat Space Infusion System/Large Volume Pump to the already included models, due to the risk that an alarm may sound to indicate a blockage (occlusion) when no occlusion exists. This will cause the pump to stop delivering medications, including critical high-risk medications like those that constrict blood vessels and raise blood pressure (vasopressors).
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves correcting devices and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact B. Braun Medical Inc. Postmarket Surveillance Department at 1-833-425-1464.
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