USA – The U.S. Food and Drug Administration (FDA) has announced a recall of Optum’s Nimbus II Plus ambulatory infusion pump system due to several malfunctions that can cause serious injuries or death. 

The recall was initiated after Optum identified several pump issues, including battery failure, upstream blockages, system errors, improper flow rate regulation, and potential drug product leakages.

The FDA has classified the recall as a Class I, the most serious type of recall, due to the potential risks associated with the defective pumps. 

The recall affects 208 devices distributed to healthcare providers and patients between August 19, 2020, and April 20, 2024.

Optum has notified all customers known to have purchased an affected Nimbus II Plus device and has asked them to stop using the pumps immediately. 

The company has also provided guidelines for patients and healthcare providers to follow until the pumps are replaced.

The specific product codes for the recalled devices are on the FDA’s website. 

Patients who own devices with a recalled product code are advised to contact Optum Homecare at (800) 950-3963 to initiate a return.

The FDA has not reported any additional injuries or deaths related to this issue beyond those identified in the original InfuTronix recall. 

Optum has reported no injuries or deaths related to the device.

The recall is the latest example of the FDA’s efforts to ensure the safety and effectiveness of medical devices. 

The agency has taken steps to improve the safety of infusion pumps, including implementing new regulations and guidelines for manufacturers.

In a statement, Optum said, “We are committed to providing safe, convenient and affordable access to medical products for our patients. The device at issue is not originally manufactured by Optum, and we are complying with FDA requirements related to this matter. Optum has not had any report of injury from our patient population related to this device.”

The FDA’s recall of Optum’s infusion pumps is a reminder of the importance of ensuring the safety and effectiveness of medical devices. 

Patients and healthcare providers should be aware of the potential risks associated with defective devices and take steps to ensure their safety.

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