Fresenius Kabi USA, LLC has announced a corrective Class I recall of an infusion pump software, LVP Software, that runs on the Ivenix Infusion System (IIS). Initiated by the firm on March 7, 2024, the action comes after multiple software anomalies were identified and found to pose a risk of serious patient harm or death.
While the company has not received any reports of injuries or death in connection to the problem, Fresenius Kabi has introduced a new software version (5.9.1) for the Ivenix Large Volume Pump (LVP) as a correction.
Designed to be used in hospital and outpatient care settings, the Ivenix Infusion System allows healthcare personnel to administer a controlled amount of fluids to patients through a variety of approved methods like “intravenous line (IVs), arterial lines, epidurals, and subcutaneous (under the skin) delivery.” The Ivenix Infusion System can be used in the treatment of adult and pediatric patients, including neonates and infants, to deliver medications and blood products like red cells or plasma, among other agents.
Those most likely to be impacted by the recall have been identified by Fresenius Kabi as patients who are treated in healthcare environments using the Ivenix Infusion System, as well as the healthcare personnel who implement the system to deliver blood and medication.
An Urgent Medical Device Field Correction sent to affected Fresenius Kabi customers on March 7, 2024 made the following requests:
- Contact a Fresenius Kabi representative at 1-978-775-8100 to have software version 5.9.1 installed on all LVPs.
- To acknowledge receipt of the letter, complete and submit the attached Customer Reply Form.
U.S. customers with additional questions about the recall may call the company at 1-978-775-8100.
As the FDA continues to oversee this recall, healthcare professionals and consumers are encouraged to report any related adverse events or quality issues
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