The FDA labeled a recall of B. Braun Medical infusion pump battery packs Class I, the most serious kind.
B. Braun’s recall is a correction, not a product removal, affecting the battery pack for its Infusomat Space large-volume pump. It affects both wireless and non-wireless batteries, model numbers 8713051U and 8713052U.
According to an FDA notice, the company recalled the infusion pump system due to faulty occlusion alarms. On certain models, an occlusion alarm may sound when no occlusion exists, causing the pump to stop the delivery of medications. That includes high-risk medications like vasopressors.
Interruption to high-risk medication delivery could lead to hemodynamic instability requiring medical intervention to prevent impairment to body structures or body functions. In some cases, this could lead to life-threatening circumstances or death.
B. Braun reported 51 complaints, one injury and one death related to this recall.
The recall reaches 10,655 devices in the U.S., distributed between Oct. 26, 2022, and July 17, 2023. The firm initiated the recall on Sept. 21, 2023.
B. Braun told customers to move the device to areas for only low-risk medication delivery and cease use for high-risk medications. They should ensure the availability of a second pump for high-risk medication administration.
The company also plans to reach out to customers and dispatch technicians to replace occlusion pressure sensors with qualified sensors. B. Braun plans for scheduled services to update the impacted devices.