fresenius kabi usa, llc

Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.

Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.

Potential for the Cassette Loading Lever to break.

Emphasizing instructions for LVP duration programming located in the IFU.

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

Potential for external cassette leaks

Potential for external cassette leaks

Potential for external cassette leaks

Potential for external cassette leaks