Early Alert: Issue with Certain Infusion Pumps from Fresenius Kabi USA

The FDA is aware that Fresenius Kabi USA has issued a letter to affected health care providers indicating a subset of Ivenix large-volume pumps (model LVP-0004; UDI 00811505030320) are to be removed from use for repair.

Fresenius Kabi reports that a subset of pneumatic valves installed in some Ivenix LVPs have an increased chance of issuing a non-recoverable pump problem alarm. All devices with the affected valves should be removed from use, if possible, to be evaluated and returned to Fresenius Kabi’s facility for repair.

• If the pneumatic valve fails, a Pump Problem alarm will be raised.
• If this failure occurs during LVP setup this could potentially delay therapy.
• If this failure occurs during an active infusion and flow is interrupted, this could lead to an
  underdose.
• Delay or interruption of a life-sustaining infusion may result in permanent disability or death.

The pump problem alarms are working as intended and will arise indicating when to act if the malfunction occurs.