Class I Recall of Fresenius Kabi Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library

Published: 08/12/2019

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

Fresenius Kabi is recalling their 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. According to the recall notice, 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 healt

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