Optum Health Care Solutions is recalling the Nimbus II Plus Ambulatory Infusion Pump System due to multiple potential failure modes, including battery issues, occlusions, system errors, and leakage. This recall, prompted by InfuTronix’s February 2024 recall, is classified as a Class I recall by the FDA, indicating a risk of serious injury or death. The affected devices, distributed between August 2020 and April 2024, will be unavailable after June 20, 2024.
The pumps are used in various healthcare settings and patient homes for delivering medications and fluids. Failures can lead to serious complications, including infections, underdosing, and severe physiological imbalances. No additional injuries or deaths have been reported beyond the initial recall.
Optum Health is replacing the recalled pumps with alternative devices, coordinating home visits for replacement and instruction. Until the replacement, patients should use new batteries, avoid clearing occlusion alarms by cycling the pump, and handle the pump carefully to prevent malfunctions. For assistance, customers can contact Optum Homecare at 800-950-3963