Some observers feel as if the FDA’s Final Rule may just be a ‘stop gap’ towards the more expansive VALID Act. Image 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.

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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.

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.

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