B. Braun Pump Gets a Class I Recall for Faulty Alarm That Can Stop Medication Infusion

The FDA has deemed B. Braun recall of its Space Volumetric Infusion Pump System due to a potentially faulty occlusion alarm that can stop the delivery of medications as class I, the most serious type of recall as use of the device can cause serious injury or death.

The recalled pump system includes several potentially affected components — large volume pump, wireless and space large volume pump, and non-wireless battery pack. On certain models, an occlusion alarm may sound when no occlusion exists, causing the pump to stop the delivery of medications.

There have been 51 complaints, one reported injury, and one death related to this recall. This recall is not a product removal, but a correction, for the 10,655 devices, distributed between Oct. 26, 2022, and July 17.

Read the FDA’s notice on the recall here.

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