FDA announces recall of Optum infusion pumps over risk of serious malfunctions
Optum issued a recall of its Nimbus II Plus ambulatory infusion pump system, used to deliver drugs and fluids to patients, after the company identified several malfunctions. These include a risk of battery failure, upstream blockages, system errors, improper flow rate regulation and a potential for drug product leakages.
The U.S. Food and Drug Administration (FDA) announced the recall Thursday, following Optum’s effort to voluntarily remove the devices from the market in April.
The pumps are typically used in home care settings.
No injuries have been reported. However, due to dangers potentialized by defective infusion pumps, and particularly risks related to faulty drug administration, the recall is ranked a Class I by the FDA—the most serious type.
What is being recalled?
A total of 208 Nimbus II Plus devices have been recalled, all of which were distributed to healthcare providers and patients between August 19, 2020, and April 20, 2024. All Optum customers known to be have purchased an affected Nimbus II Plus were notified in a letter sent on on April 18, 2024, about hazards associated with the pumps, with providers and patients asked to stop using them and seek an immediate replacement.
The specific product codes for the recalled devices can be found here.
Next steps
In its letter to customers, Optum outlined steps for the defective Nimbus II pumps to be exchanged. Until then, Optum said all medical professionals and patients should use an alternative pump.
If a patient cannot find an alternative pump, Optum recommends they do the following until their pump is replaced:
- Only use new batteries
- Do not cycle the battery to clear an occlusion alarm. If the occlusion alarm cannot be cleared, use a new pump. Silencing the alarm does not solve the problem.
- For ambulatory use of the Nimbus II pumps, carry the drug product dispensing pouch in a carrying pack. Impeding the tubing set or placing pressure on the device may cause it to malfunction.
If the patient notes any difficulties or abnormalities with the pump or its accessories, Optum said they should immediately stop using the device and notify their provider.
Those who own devices with a recalled product code are advised to contact Optum Homecare at (800) 950-3963 to initiate a return.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.