Sam Brusco, Associate Editor11.20.23
The U.S. Food and Drug Administration has identified B. Braun Medical’s September 21 recall of its Infusomat Space large volume pump, wireless and Infusomat Space large volume pump, non-wireless battery pack as Class I.
The pump system was recalled because of faulty occlusion alarms. On some models, an alarm may sound when no occlusion exists, causing the pump to stop medication delivery, such as high-risk medications like vasopressors. Interrupting infusion of high-risk medications can lead to hemodynamic instability, which needs medical intervention to prevent permanent impairment to body structures or functions. In some cases, this can be life-threatening or lead to death.
So far, the company has reported 51 complaints, one injury, and one death related to the recall.
B. Braun Medical’s September 21 Important Medical Device Advisory urged customers to move the device to areas where only low-risk medication is delivered and not use it for high-risk medications. The company also requested customers to ensure a second pump is available when high-risk medication is being infused to allow continued use of the impacted device.
The company said it will reach out to customers and send technicians to replace the occlusion pressure sensors with a second source of qualified sensors. Customers were also provided with stickers to mark the affected units, as well.
The pump system was recalled because of faulty occlusion alarms. On some models, an alarm may sound when no occlusion exists, causing the pump to stop medication delivery, such as high-risk medications like vasopressors. Interrupting infusion of high-risk medications can lead to hemodynamic instability, which needs medical intervention to prevent permanent impairment to body structures or functions. In some cases, this can be life-threatening or lead to death.
So far, the company has reported 51 complaints, one injury, and one death related to the recall.
B. Braun Medical’s September 21 Important Medical Device Advisory urged customers to move the device to areas where only low-risk medication is delivered and not use it for high-risk medications. The company also requested customers to ensure a second pump is available when high-risk medication is being infused to allow continued use of the impacted device.
The company said it will reach out to customers and send technicians to replace the occlusion pressure sensors with a second source of qualified sensors. Customers were also provided with stickers to mark the affected units, as well.