The FDA is aware that Fresenius Kabi USA began issuing notifications to affected health care providers recommending certain software versions of the Ivenix Infusion System be updated related to a potentially high-risk device issue.
Fresenius Kabi USA reports two anomalies associated with software versions 5.9.2 and earlier. These anomalies have the potential to cause serious patient harm or death, including patients being underdosed or over infused. Underdosage may lead to patient harm including temporary arrhythmias, hyperglycemia, hypo- or hypertension, undersedation, and clotting changes. Over infusion may lead to patient harm including hyper- or hypoglycemia, hypo- or hypertension, electrolyte imbalance, oversedation, temporary arrhythmias, clotting changes, and unsuccessful resuscitation.
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