Company: Fresenius Kabi USA, LLC
Date of Enforcement Report: 10/6/2022
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
Fresenius Kabi USA, LLC
VOLUME OF PRODUCT IN COMMERCE
Domestic distribution to NJ and WI.