FDA: Class 1 infusion system recall expanded

Editor's Note

B. Braun Medical Inc. has expanded last year’s recall of lnfusomat Space Infusion Pump systems to include more models. Designated by the US Food and Drug Administration (FDA) as Class 1—the most serious category indicating risk of severe injury or death—the recall was motivated by the risk of a false alarm indicating occlusion when none exists.

According to FDA’s September 17 report, the recall adds lnfusomat Space Infusion System/Large Volume Pump to the already included models, Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless Battery Pack. When the alarm sounds, the pump stops delivering medications such as vasopressors, potentially leading to hemodynamic instability and death.  

According to FDA, there has been one reported injury and one report of death. The full report recommends actions for users and customers.