FDA Warns About Failure Risks with Fresenius Ivenix Infusion Pumps

Early alert is part of an FDA pilot program intended to warn about dangerous risks associated with medical devices, before a recall is officially announced.

A valve problem with Fresenius Ivenix Infusion Pumps may cause the devices to suddenly stop working, which could lead to serious side effects, injuries and even patient deaths, according to an early warning issued by federal regulators.

The Ivenix LVP is a large-volume infusion pump designed to deliver life-saving therapies via fluids and medications to patients. The pump provides fluids and medications intravenously, into arteries, into the spine or under the skin. Fluids can be either antibiotics, painkillers, hormones, insulin or chemotherapy drugs.

The U.S. Food and Drug Administration (FDA) issued the early warning alert about Fresenius Kabi USA Ivenix Infusion Pump failures on December 11, indicating that a problem with pneumatic valves may prevent the device from providing life-saving medications or fluids to patients.

The alert comes a few days after Fresenius sent letters to healthcare providers about the valve issue and risk of Ivenix infusion pump failures, and is part of an FDA pilot program designed to warn about dangerous risks associated with medical devices before an official recall is announced.

When the agency becomes aware of a potentially high-risk device that may cause injuries to patients, it will now attempt to alert the public in advance of any official recall, to help prevent unnecessary injuries and deaths.

Ivenex Infusion Pump Problems

The Fresenius notice indicated pneumatic valves installed in some Ivenix pumps may fail suddenly. If the pneumatic valves fail, the pumps may activate a non-recoverable pump problem alarm, causing a potential delay in delivering therapy to the patient. This may interrupt an active infusion of medications or fluids, which can lead to serious health side effects, permanent disability, and may even result in death.

Because of the valve problem, Fresenius sent customers a letter recommending the products be returned for repair. However, in the meantime, they also recommended healthcare providers isolate any affected pumps, so they are not used.

Healthcare providers have also been urged to post a list of affected serial numbers in public areas of their facilities, so employees are aware if a pump may be at risk of failing.

If an affected pump must be used to deliver life-saving medications, Fresenius indicates it is crucial to monitor the patient closely and make sure to have a backup pump available in case there is a failure. If a problem does occur, healthcare providers have been told to stop using the pump and switch to the backup pump.

So far, no injuries or deaths have been reported in connection with the Ivenix pump valve problem.

Ivenix Infusion Pump Recalls Issued Earlier in 2024

This isn’t the first serious problem to plague Fresenius Ivenix Infusion Pumps this year. In September 2024, the manufacturer recalled Ivenix pumps after two people were injured due to a manufacturing defect that allowed too much medication to be delivered to the patients during therapy.

Then again in October 2024, the FDA announced another recall involving Ivenix Infusion Pumps after a problem with the device software was discovered, which posed a cybersecurity risk and could delay the delivery of important fluid therapy to patients.

According to the FDA, due to the new problem with the Ivenix pumps, all affected devices should be removed from use and sent to Fresenius to be evaluated for repair.

Injuries or side effects should be reported to the FDA’s MedWatch Adverse Event Reporting Program.