Less than a year after putting down $240 million to acquire of Ivenix and its sensor- and software-backed infusion pump, Fresenius Kabi is recalling more than 1,500 of them.
The recall affects only the LVP-0004 model of the large-volume pump, according to an FDA notice published Wednesday. The systems were distributed in just a handful of U.S. states—and nowhere internationally—between late October 2021 and January of this year.
Fresenius Kabi officially began the recall March 8, per the notice, but it wasn’t until this week that the FDA handed down a Class I rating for the incident, indicating a heightened risk of injury or death associated with the issue.
Infusion pumps are used to deliver blood, medications and other fluids to patients through an IV over a set period of time.
The Ivenix infusion system—cleared by the FDA in 2019—is designed to be “smarter” than a typical infusion pump, according to its maker. The pump itself is equipped with an easy-to-use touchscreen and with real-time guidance tools that immediately compare programmed dosages to those recommended in the built-in drug library.
The pump connects to software that links with a hospital’s electronic health record system to automatically input dosing data into patients’ records. Clinicians can also view all of their patients’ infusion data and track usage of the pumps on a computer or tablet equipped with Ivenix’s own dashboard software.
According to the FDA, Fresenius Kabi began the recall after discovering that a leak in the system could allow fluids to flow into the administration set, which connects the pump to the patient. If that happens, the leak could damage the pump’s internal electrical system, causing the entire pump to lose power—which could in turn keep patients from getting the fluids they need.
To date, the regulator said Fresenius Kabi has received 14 complaints related to the issue, none of which include any reports of a patient injury or death.
In a letter sent to users of the 1,546 affected infusion systems last month, Fresenius Kabi said it would soon begin reaching out to schedule repairs of the systems, or total replacements if repairs aren’t possible.
In the meantime, healthcare providers can continue using the systems, but the company recommended that they have a backup large-volume infusion pump at the ready, especially in cases where the system is being used to deliver life-sustaining fluids. They should pay close attention to any alarms or alerts issued by the systems and switch to a different pump if the Ivenix model is unable to start or resume fluid delivery.
Clinicians should also regularly inspect the administration set loading area of the pumps to check for fluid buildup and to quickly clean up any spills there or excess liquid leftover after a pump is disinfected, the company said.