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.