B. Braun’s Infusion Pump Recall Receives FDA Class I Tag

A new medicine delivery device has been recalled for the fourth time this month alone, and the FDA sent out a notice formally conferring a Class I label upon it. This label indicates that there is an increased risk of serious harm or fatality associated with the product. This recall is specific to the Infusomat Space volumetric infusion pump system manufactured by the German company B. Braun Medical.

Patients of all ages can receive drugs, blood, and other fluids using the Infusomat Space, which is a large-volume infusion pump. These pumps are utilized in hospital settings. The system may be purchased in both a wireless and a non-wireless configuration, with the latter variant requiring an additional battery pack to function.

According to the notification that was issued by the FDA on mid November, B. Braun initiated the recall in September after discovering that some of the pumps may sound alerts warning of obstructions in the system even when there have been no real blockages.

The occlusion alarms of the system autonomously cause a full stop of the planned medicine administration, which means that defective alarms have the ability to disrupt the supply of potentially vital fluids to patients. According to the regulator, this is an occurrence that might be life-threatening or even deadly for the patients.

According to the notification, as of the current date, B. Braun has received a total of 51 complaints regarding the recall, in addition to accounts of one patient injury and one fatality.

Only specific kinds of Infusomat Space devices that were issued between the end of October 2022 and the middle of July 2023 are impacted by the recall. There were more than 10,600 of these devices marketed in the U.S. alone.

Instead of a complete removal of the goods, the recall is being referred to as a “product correction.” B. Braun is now working to replace the malfunctioning occlusion sensors that were installed during scheduled service. In the interim, medical professionals who are in possession of any of the infusion pumps that have been recalled have been instructed to only use them to administer low-risk drugs and to switch to a replacement device in circumstances in which high-risk pharmaceuticals are required. 

This recall is the latest in a string of recent recalls that have each concentrated on medication delivery devices and have all been given Class I ratings by the FDA.

In the previous week alone, the regulatory agency issued notifications, firstly to Cardinal Health regarding specific variants of its Monoject syringes, identified as incompatible with conventional syringe pumps. Following that, notices were given to Fresenius Medical Care due to concerns about potential leaks in their Sanxin single-use sterile syringes. Lastly, Baxter received notifications related to its Novum IQ syringe infusion pumps, citing a software bug that might lead to an inaccurate indication of the completion of an infusion.