Summary: Fresenius Kabi advises updating Ivenix Infusion System software (versions 5.9.2 or earlier) to avoid two anomalies risking under- or over-infusion. Repeatedly pausing audio can halt pumping, and simultaneous primary completion with a new secondary infusion may revert to an unchecked primary rate. No related injuries or deaths are reported.
Key Takeaways:
- Underdosing or over-infusion events can cause serious patient harm, including arrhythmias and glycemic imbalance.
- Fresenius Kabi recommends upgrading to software version 5.10 to mitigate these anomalies and ensure safe infusion therapy.
Fresenius Kabi USA has issued a letter to affected healthcare providers recommending certain software versions of the Ivenix Infusion System be updated related to a potentially high-risk device issue.
Software Anomalies Leading to Possible Patient Harm
Fresenius Kabi USA reported the following anomalies associated with software versions 5.9.2 and earlier. These anomalies have the potential to cause serious patient harm or death. On Jan. 10, 2025, the company began notifying affected customers recommending customers update the LVP software to version 5.10.
- Repeated Pause Audio
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, under-sedation, and clotting changes. - Secondary Infusion Switching to Primary Infusion
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 programmed 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.
RELATED: Fresenius Kabi Issues Alert for Ivenix LVP Pump Alarm Malfunction
About the Ivenix LVP Software
The firm has not reported any injuries or deaths associated with this issue.
The Ivenix LVP software is the application embedded in the Ivenix Infusion System. The LVP software controls the functioning of the LVP and exchanges information with Infusion Management System (IMS) applications. When loaded with an administration set, the LVP delivers infusion therapy to an individual patient.