Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library

August 12, 2019

Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Due to a "Low Priority" "Keep Vein Open (KVO), End of Infusion" Alarm and Multiple Software Errors. The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.

Recalled Product

  • Volumat MC Agilia Infusion System and Vigilant Drug Library
  • Models
    • Volumat MC Agilia Z021135, Software Versions 1.7 and 1.9a
    • Vigilant Drug Library Z073476, Software Versions 1.0 and 1.1
  • Lot Numbers: All
  • Manufacturing Dates: All
  • Distribution Dates: All
  • Devices Recalled in the U.S.:
    • Volumat MC Agilia - 9,461
    • Vigilant Drug Library - 83
  • Date Initiated by Firm: June 21, 2019

Reason for recall

When enabled, the "Keep Vein Open (KVO), End of Infusion" alarm triggers when the infusion is complete. This results in the therapeutic rate of a medication changing to a non-therapeutic rate, as defined by the KVO rate. KVO alarms should be high priority. If a health care provider fails to respond to a "KVO, End of Infusion" alarm for a critical medication, a delay in care and/or under-infusion of medication can take place, which may lead to death or serious injury because the patient will be receiving a non-therapeutic rate of medication.

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