Fresenius Kabi recalls Volumat MC Agilia infusion pump and Vigilant Agilia drug library

0

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” FDA (2019).

Extract:

FDA report “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.

Fresenius Kabi will change their “Keep Vein Open (KVO), End of Infusion” alarm from a “low priority” to a “high priority” alarm to ensure the health care provider knows the infusion has completed. There has been one death reported outside of the United States related to a norepinephrine infusion where a health care provider did not adjust the “Volume to be Infused” after changing the drug bag and then did not notice the pump’s “low priority” “KVO, End of Infusion” alarm. No other injuries have been reported in the rest of the world or in the United States.

Fresenius has also identified four software errors occurring with both the Volumat MC Agilia Infusion System and Vigilant Drug Library that may cause over-infusion or under-infusion of fluids/medications. These software errors could cause serious patient harm or death. There have been zero injuries and 14 complaints reported related to these software errors.”

You may also be interested in…


Full Alert

Share.

Comments are closed.