If your email program has trouble displaying this email, view as a webpage.

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.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.

Questions?

Customers in the U.S. with questions about this recall should contact Fresenius Kabi USA at Ivenix_support@fresenius-kabi.com or 1-855-354-6387.