The US Food and Drug Administration (FDA) has issued an early alert over a potential high-risk issue with Fresenius Kabi’s infusion pumps.

The Ivenix large-volume pump (LVP) is designed to deliver fluids and medications from one of two inlet source containers to patients through a single outlet.

The agency’s early alert comes after Fresenius Kabi, the US-based division of Germany-headquartered healthcare company Fresenius, issued a letter on 5 December. It informed customers that a subset of pneumatic valves installed in some of the Ivenex LVPs have an increased chance of issuing a non-recoverable pump problem alarm.

The company’s letter advised customers that all devices bearing unique device identifier (UDI) 00811505030320 may experience the issue and that all affected devices should be removed from use to be evaluated and returned to Fresenius Kabi’s facility for repair.

If the removal of some or all the potentially affected devices from active use is not feasible, the FDA advises that sites using the LVP enhance clinical monitoring during use and ensure an additional LVP is available for situations where an interruption in infusion could be dangerous.

If a pump problem alarm is inadvertently raised during use, the agency advises users to reconfigure the infusion on another LVP and report the issue to the relevant biomedical engineers at their institution.

The FDA’s early alert communication is part of a communications pilot to enhance the agency’s medical device recall programme. Enacted by the FDA’s Center for Devices and Radiological Health (CDRH), the pilot focuses on improving the timeliness of communications to the public around corrective actions being taken by companies with devices believed to be high-risk recalls.

In September 2024, the FDA issued a recall on Fresenius Kabi’s Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port.