FDA Identifies Recall of B. Braun Medical Pump System as Most Serious

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....