The FDA this week labeled Fresenius Kabi’s recall of some Ivenix Infusion Systems (IIS) as Class I, the most serious kind.
Fresenius Kabi USA issued the recall of Ivenix Infusion System LVP software, its infusion pump software, due to an issue of multiple software anomalies occurring that can potentially result in serious patient harm or death.
The company issued the recall on March 7, 2024. It affects 17 products under the name LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0, with distribution dates March 6, 2023 to March 20, 2024. There have been no reports of injuries or deaths associated with this issue, according to the FDA warning letter.
Fresenius Kabi will remedy the issue by releasing a new software version for the Ivenix Large Volume Pump. This recall affects people who are treated in a healthcare setting using the system and healthcare personnel who use the IIS to deliver blood and medications to patients in healthcare settings.
This is Fresenius Kabi’s second Ivenix recall in recent months. In January, the FDA labeled the company’s recall of the LVP-0004 model of the Ivenix large-volume pumps as Class I. The company recalled the pump because some units have mechanical issues with the fluid valve pins. This issue may cause the pins — located inside the pump’s internal housing — to not move properly. Instead of going where they should, the pins could impact the side of a sensor.
Fresenius Kabi’s Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids to patients through accepted methods, such as intravenous lines, arterial lines, epidurals and subcutaneous delivery. The fluids typically include medications, blood products or other agents needed to treat adult and pediatric patients.
