B. Braun Medical Adds Another Infusomat Pump to 2023 Recall

In November 2023, B. Braun Medical initiated a correction of its Infusomat Space Large Volume Pump wireless, and Infusomat Space Large Volume Pump non-wireless battery pack after reports of faulty occlusion alarms.

Now, the company has expanded the recall to include the Infusomat space Infusion System/Large Volume Pump. The Infusomat pump systems are used for the delivery of fluids, medications, blood, and blood products.

The correction refers to the risk of occlusion alarms when no occlusion exists. When the occlusion alarm sounds, the pump stops the delivery of medication. Severe adverse health consequences can occur when high-risk mediations like those that constrict blood vessels and raise blood pressure are stopped without warning. Compiling the data from both corrections, there have been 51 complaints, one reported injury and one death associated with the issue.

For all three devices, B. Braun Medical’s recommendations have stayed consistent. If possible, do not use affected products to deliver high-risk medications until occlusion sensor can be replaced. If the devices must be used to deliver high-risk medications before correction can happen, have a second pump available where possible and additional monitoring may be required. Additionally, the company said to power the device down for 48 hours if it exhibits frequent false occlusion alarms.

In the recall notice, B. Braun Medical said that it is working to schedule and update impacted devices.