OptumHealth Nimbus II Pump System Identified as Class I Recall

OptumHealth Care Solutions’ recall of its Nimbus II Infusion Pump systems has obtained Class I status from FDA. The recall is a direct response to InfuTronix’s recall of the same device in February.

The Optum Nimbus II Plus is an ambulatory infusion pump system that delivers medications or fluids to patients under supervision or direction of a physician or other healthcare professional. The device is used for subcutaneous, perineural or epidural, and intravenous infusions. Additionally, the pumps are sometimes used for patients to deliver their own pain medications.

OptumHealth is recalling the Nimbus II Plus in response to the February 21 InfuTronix recall of Nimbus and Nimbus II Infusion Pump systems after reports of multiple potential failure modes, including battery failure, upstream blockage, system errors, drug product leakage, high or low flow rate, or damaged housing. The company highlighted that the pumps will no longer be available or supported after June 20.

Using affected pumps, according to FDA, could result in infection from microbial contamination due to leakage, interruptions or delays in treatments from “unnoticed occlusions or leaks may lead to underdosing of vital medications and fluids resulting in dangerous changes in blood pressure, dehydration (water loss), and electrolyte imbalance; seizures, shock and organ failure may occur. Use of these products may lead to serious injury or death,” the FDA notice wrote.

When InfuTronix first initiated the recall, it reported 3,698 complaints, six injuries, and one death associated with the issue. Since then, OptumHealth has seen no additional injuries or deaths connected to Optum Nimbus II Plus.

Starting February 21, 2024, InfuTronix sent customers an Urgent Medical Device Removal letter informing that specifically identified Nimbus infusion pump systems were being removed from the market and noted that the products would no longer be supported by the company after June 20. The recall was then updated to FDA Class I in April.

It was on April 18, that OptumHealth entered the conversation, also sending a recall notification letter to customers informing them about the Nimbus II recall and its plans to replace the pumps with an alternative for all patients currently using them.

OptumHealth outlined what customers could expect from obtaining the alternatives, including that the replacement would take place through a home visit to provide instruction on the new device and removal of the old one, a nurse would contact the patient to schedule the replacement, and the nurse would then retrieve the old pump and cassettes for return to the manufacturer. The company highlighted that patients having issues with their device should contact the nurse as soon as possible to prioritize pump replacement.

Also included in the letter were recommendations for pump use while waiting for the new one, like only using new batteries as replacements, not cycling the battery to clear an occlusion alarm, and carrying the drug product dispensing pouch in a carrying pack for ambulatory pump use. In all, the company said that patients experiencing any difficulties or abnormalities with the pump or accessories should immediately discontinue use and notify the Optum nurse or healthcare provider.