OptumHealth reported no additional injuries or deaths in its recall. Credit: Tada Images / Shutterstock.

German-based medical and pharmaceutical device company B. Braun Medical has issued a product recall correction of its Infusomat Space Volumetric Infusion Pump System including the Infusomat Space Large Volume Pump, Wireless and Infusomat Space Large Volume Pump, and Non-Wireless BATTERY PACK.

Following 51 complaints, one reported injury, and one death the US Food and Drug Administration (FDA) labelled the recall as class I recall meaning the devices posed a serious risk of injury and death.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

A malfunctioning occlusion alarm on the products is what triggered the recall. Some models have this alarm to monitor the blockage or closing of an opening or blood vessel and when this alarm goes off the pump will cease the delivery of medications, such as high-risk medications like vasopressors. Disruptions to the delivery of such medications can cause hemodynamic instability which untreated can lead to permanent damage to body structures or body functions.

B. Braun Medical issued an Important Medical Device Advisory letter on September 21, 2023. The letter urged its users to use the device in areas that only receive low-risk medication and to have a backup device.

Those identified as potential risks include patients who require intermittent or continuous delivery of parenteral fluids, medications, blood, and blood products especially those that require high-risk medication.

See Also:

The company also claimed it would send out technicians to replace the occlusion pressure sensors with a second source of qualified sensors. Scheduled services to update the devices are being rolled out but in between B. Braun Medical has advised to only use non-impacted devices for the delivery of high-risk medications.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.