(Reuters) – The U.S. Food and Drug Administration (FDA) on Friday said it had identified the recall of B. Braun Medical Inc’s medicine-delivering pump system as most serious.
The Pennsylvania-based company had recalled some models of its Infusomat Space Volumetric infusion pump system in September due to faulty occlusion alarms, which may cause the pump to stop the delivery of medications pre-emptively or cause interruption.
Occlusion alarms are used to indicate when the pump is unable to sustain the set flow rate and therefore pressure in the line begins to increase.
The pumps are used in delivery of high-risk medications such as vasopressors, given to those with low blood pressure to make blood vessels constrict or become narrow. Interruptions in high-risk cases may be life-threatening, or could lead to death, the agency said.
There have been 51 complaints, one death related to this recall and one reported injury, the FDA said.
The company has asked customers to not use the device for high-risk medications, and only use it for delivery of low-risk medicines.
About 10,655 devices, which were distributed between Oct. 26, 2022 and July 17, 2023, have been recalled by the company.
B. Braun Medical did not immediately respond to a Reuters request for comment.
(Reporting by Sriparna Roy in Bengaluru; Editing by Maju Samuel)