For the fourth time already this month, the FDA has issued a notice formally bestowing a Class I label—denoting a heightened risk of serious injury or death—upon a recall of yet another drug delivery device.
This time around, the recall was initiated by B. Braun Medical, and it concerned the German devicemaker’s Infusomat Space volumetric infusion pump system.
The Infusomat Space device is a large-volume infusion pump that’s used in hospital settings to deliver medications, blood and other fluids to patients of all ages. The system is available in both wireless and non-wireless iterations, with the latter requiring a separate battery pack.
According to the Nov. 17 FDA notice, B. Braun began the recall in September after learning that some of the pumps may send out alarms warning of occlusions in the system when no blockages have actually occurred.
The system’s occlusion alarms automatically trigger a full stop of the programmed medication delivery, meaning the faulty alarms may interrupt the delivery of potentially life-sustaining fluids to patients—an event that could be life-threatening or even fatal, per the regulator.
To date, according to the notice, B. Braun has received 51 complaints, plus reports of one patient injury and one death, related to the recall.
The recall affects only certain models of the Infusomat Space devices that were distributed between late October 2022 and mid-July of this year, with more than 10,600 of the affected devices sold in the U.S.
The recall is denoted as a product correction, rather than a full product removal: B. Braun is in the process of replacing the faulty occlusion sensors in scheduled services. In the meantime, healthcare providers in possession of any of the recalled infusion pumps have been advised to use them only to deliver low-risk medications and to swap in a replacement device in situations where high-risk medications are needed.
This is the latest in a recent series of recalls that have all focused on drug delivery devices and all of which have earned Class I ratings from the FDA.
Last week alone, the agency doled out notices first to Cardinal Health—for certain versions of its Monoject syringes that were found to be incompatible with standard syringe pumps—then to Fresenius Medical Care’s potentially leaky Sanxin single-use sterile syringes and, finally, to Baxter’s Novum IQ syringe infusion pumps for a software error that could cause the pumps to inaccurately indicate that an infusion has finished.