Infusion pump problems prompt early FDA safety warning

Editor's Note

Risk of delayed therapy and death related to Ivenix large-volume infusion pumps is prompting supplier Fresenius Kabi USA to pull a subset of the devices from the market, according to an early alert from The US Food and Drug Administration (FDA).

Issued December 11, the early alert is part of FDA’s Communications Pilot to Enhance the Medical Device Recall Program, which aims improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls. “Fresenius Kabi USA reports that a subset of pneumatic valves installed in some Ivenix LVPs have an increased chance of issuing a non-recoverable pump problem alarm,” the agency reports, highlighting the risk of death or permanent disability resulting if failure occurs during an active infusion.  

No deaths or injuries have been reported. The full announcement offers additional specifics about the affected devices, as well as the manufacturer’s instructions for mitigating risks and returning the devices for repair.