B. Braun Medical is warning customers of an issue with about 10,000 pumps after receiving 51 complaints and reports of one injury and one death.
The medical devicemaker's Infusomat Space Volumetric Infusion Pump System might have faulty occlusion alarms and suddenly stop delivering medications, "such as high-risk medications like vasopressors," the FDA said Nov. 17.
The agency labeled the concern as a Class I recall, the most serious type. B. Braun Medical is not recalling the 10,655 devices; rather, the company is recommending healthcare workers use the pumps for low-risk drugs, or have a backup pump available for high-risk medications