On November 17, 2023, the U.S. Food and Drug Administration (FDA) announced that B. Braun Medical, Inc., is recalling its Infusomat Space Volumetric Infusion Pump System because of faulty occlusion alarms, causing the pump to stop delivering medications, including high-risk medications such as vasopressors. Interrupting the infusion of high-risk medications may lead to hemodynamic instability, which may be life-threatening or lead to death in some cases. FDA is aware of 51 reports, one injury, and one death related to the recall. The agency has identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

FDA update

The Infusomat Space Volumetric Infusion Pump System, which includes the wireless pump and non-wireless battery pack pump, is for use by trained healthcare professionals in healthcare facilities on adults, pediatrics, and newborns for the intermittent or continuous delivery of parenteral fluids, medications, blood, and blood products.

The recall involves 10,655 devices distributed in the United States from October 26, 2022–July 17, 2023, carrying the model numbers 8713051U and 8713052U.

On September 21, 2023, B. Braun Medical, Inc., sent all affected customers an important medical device advisory that informed them to: 

  • Move the device to areas where only low-risk medication is delivered and to not use the device for high-risk medications. 
  • Ensure a second pump is available if high-risk medication is being infused, thereby allowing the continued use of the affected device. 

B. Braun Medical, Inc., said it will schedule technician services to replace the occlusion pressure sensors with a second source of qualified sensors and provided customers with stickers to mark the affected units.

For questions about the recall, contact B. Braun Medical, Inc., at 800-627-PUMP (800-627-7867), or view additional FDA resources about the recall:

Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.