Braun Medical Infusion Pump Recall

Braun Medical has recalled (Class 1) its Infusomat Space Volumetric 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, such as high-risk medications like vasopressors,” a recall notice says. Any high-risk medication infusion disruption could lead to “hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions,” it says. To date, 51 complaints have been reported, including one death related to the issue.
 
The device, which includes the Infusomat Space Large Volume Pump, Wireless and Infusomat Space Large Volume Pump, and Non-Wireless Battery Pack, is used by healthcare professionals for the intermittent or continuous delivery of parenteral fluids, medications, blood, and blood products.