Early Alert: Infusion Pump Software Issue from Fresenius Kabi USAAffected Product
The FDA is aware that Fresenius Kabi USA has issued a letter to affected health care providers recommending certain software versions of the Ivenix Infusion System be updated related to a potentially high-risk device issue:
- Large Volume Pump (LVP) Software, version 5.9.2 and earlier
- Product code: LVP-SW-0005
- UDI: 00811505030122
This software is part of the Ivenix Infusion System and is embedded in the Ivenix Large-Volume Pump, LVP-0004 (Pump UDI: 00811505030320)
Reason for Alert
Fresenius Kabi USA reports the following anomalies associated with software versions 5.9.2 and earlier. These anomalies have the potential to cause serious patient harm or death.
If during an alarm condition the Pause Audio option is repeated 70 times or more, it will result in the pump becoming nonfunctional, which may lead to the patient being underdosed or delay their therapy. Underdosage may lead to patient harm including temporary arrhythmias, hyperglycemia, hypo- or hypertension, undersedation, and clotting changes.
If a secondary infusion is started at the exact moment a primary infusion completes, then the pump will switch to primary once the secondary infusion completes and Volume to be Infused (VTBI) reaches 0. Then, the primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty, which may lead to the patient being over infused. Over infusion may lead to patient harm including hyper- or hypoglycemia, hypo- or hypertension, electrolyte imbalance, oversedation, temporary arrhythmias, clotting changes, and unsuccessful resuscitation.
The firm has not reported any injuries or deaths associated with this issue.