The U.S. Food and Drug Administration (FDA) is aware that Fresenius Kabi has issued a letter to affected customers recommending all Ivenix Large Volume Pump Software (versions 5.10.1 and earlier) be corrected prior to continued use.
Fresenius Kabi has found two anomalies within the affected software that could cause serious patient harm or death. These issues may cause delays or interruptions to infusion. The extent of harm resulting from delayed or interrupted therapy depends on the time taken to identify and resolve the issue, the patient’s underlying medical condition, and the criticality of the administered therapy.
As of November 18, Fresenius Kabi has reported two serious injuries and no deaths associated with this issue.
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
