(Reuters) – The U.S. Food and Drug Administration (FDA) said on Friday it has determined the recall of B. Braun Medical Inc’s drug delivery pump system to be the most serious.
The Pennsylvania-based company recalled some models of its Infusomat Space Volumetric infusion pump system in September due to faulty blockage alarms, which could cause the pump to proactively stop delivering medications or cause an outage.
Blockage alarms are used to indicate that the pump is unable to maintain the specified flow rate and thus the pressure in the line begins to increase.
Pumps are used to deliver high-risk medications such as vasopressors, which are given to those with low blood pressure to make blood vessels constrict or become narrow. The agency said outages in high-risk cases could be life-threatening or could lead to death.
The FDA said there were 51 complaints, one death associated with this recall and one injury.
The company asked customers not to use the device for high-risk medications, and to only use it to deliver low-risk medications.
The company has recalled approximately 10,655 devices, which were distributed between October 26, 2022 and July 17, 2023.
B. Brown Medical did not immediately respond to a Reuters request for comment.
(Reporting by Sriparna Roy in Bengaluru; Editing by Maju Samuel)
