Optum joins FDA and manufacturer in recall of infusion pumps that killed a patient

OptumHealth Care Solutions, a subsidiary of UnitedHealth Group, joined the manufacturer and the U.S. Food and Drug Administration on Thursday in recalling an infusion pump system that has killed at least one patient.

Eden Prairie-based Optum’s Nimbus II Plus infusion pumps – part of its home care infusion system – are one of several similar products made by Massachusetts-based InfuTronix that are subject to the Class 1 recall, the FDA’s most serious recall because it poses a risk of serious injury or death. The infusion pump system delivers medications and fluids to a patient via infusions or injections, including as patient-controlled analgesia (PCA) for pain management.

InfuTronix had already recalled more than 52,000 pumps in February after 3,698 complaints, six serious injuries and one death were reported related to the pump problems. Possible problems included battery failure, medication leaks, incorrect flow rates and system failure. These problems can lead to microbial contamination and underdosing, leading to dangerous blood pressure changes, dehydration, seizures, shock and/or organ failure.

Optum has not reported any injuries or deaths beyond those listed in the InfuTronix recall. The Optum recall affects 208 devices.

“We are committed to providing our patients with safe, convenient and affordable access to medical products,” Optum said in a statement. “The device in question was not originally manufactured by Optum and we comply with FDA requirements regarding this. Optum has not received any reports of injuries to our patients related to this device.”

Representatives of InfuTronix were not available for comment.