Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi USA, LLC
The hazard
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. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Model Number: LVP-0004Model UDI-DI: 00811505030320Model All Serial/Lot Numbers:UPC 00811505030320Would you have heard about this one?
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