Dive Brief:
- Fresenius Kabi recalled some of its large volume infusion pumps over a software problem that can lead to delays or interruptions of therapy and inaccurate battery information, according to a Food and Drug Administration notice posted last week.
- The company’s Ivenix large volume pumps are used to deliver fluids or medications to patients. Fresenius told healthcare providers to make sure the latest software versions are installed on the Ivenix Infusion Management System and the large volume pump.
- Fresenius has had multiple recalls of its Ivenix large volume pumps in recent years. The devices were also the subject of a warning letter in 2024.
Dive Insight:
Fresenius sent a letter to customers in November warning them about the problem. The FDA classified the recall a month later as Class I, its highest risk category, according to an enforcement report. The recall has been tied to two serious injuries as of Nov. 18.
The older software is associated with two anomalies. Ivenix pumps operating on battery power for an extended period of time may inaccurately report the remaining battery capacity, resulting in an unexpected shutdown, the company said. Fresenius recommended keeping the device plugged in during use until users update to the latest software version.
In another anomaly, if a clinician enters a rate with two leading zeroes on the pump, pressing “back” or “OK” can cause the pump to enter a fail-stop alarm state, freezing the interface. This could delay or interrupt therapy if the reprogramming stops an active infusion, according to the recall notice.
The pumps have been the subject of multiple recalls. Fresenius recalled administration sets for its large volume pumps in January, after some of the devices were improperly assembled. In 2024, the FDA also issued an early alert for a problem related to a pump alarm that could interrupt treatment.
Fresenius received a warning letter in 2024 related to the Ivenix large volume pumps after FDA inspectors found the company took too long to complete investigations and did not document the risk of certain problems with its devices.
Fresenius acquired Ivenix in 2022 for $240 million.
