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  5. OptumHealth Care Solutions Recalls Nimbus II Infusion Pump Systems Under Recall by InfuTronix, LLC
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OptumHealth Care Solutions Recalls Nimbus II Infusion Pump Systems Under Recall by InfuTronix, LLC

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • Product Name: Optum Nimbus II Plus Ambulatory Infusion System
  • Product Codes: See Recall Database entry
  • Distribution Dates: August 19, 2020 to April 20, 2024
  • Devices Recalled in the U.S.: 208
  • Date Initiated by Firm: April 18, 2024

Device Use

The Optum Nimbus II Plus (also known as the Nimbus II – Optum Homecare Infusion), is an ambulatory infusion pump system, is intended to deliver medications and/or fluids to a patient under the direction or supervision of a doctor or other certified health care professional. These devices are used for infusions under the skin (subcutaneous), in the spaces between nerves (perineural or epidural), or into blood vessels (intravenous). The pumps are sometimes used for patients to deliver their own pain medications (patient-controlled analgesia or PCA).

Nimbus infusion pump systems are used in hospitals, other healthcare facilities, and in nonclinical environments such as patient homes.

Reason for Recall

OptumHealth Care Solutions, LLC, is recalling their Nimbus II Plus infusion pumps (also known as the Nimbus II – Optum Homecare Infusion) in direct response to the February 21, 2024, InfuTronix recall of these devices due to multiple potential failure modes that may include battery failure, upstream blockage (occlusion), system errors, drug product leakage, high or low flow rate, or damaged housing. The devices will not be available or supported after June 20, 2024.

Using affected pumps could cause infection from microbial contamination after loss of the sterile barrier (leakage), interruptions or delays in therapy 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.

OptumHealth Care Solutions reports no additional injuries or deaths related to this issue beyond those in the original InfuTronix recall.

Who May be Affected

  • Health care providers using Nimbus II Plus infusion pump systems.
  • Patients who currently receive infusions using Nimbus II Plus infusion pump systems or whose care might typically be delivered using these infusion pumps.

What to Do

On April 18, 2024, OptumHealth Care Solutions sent a recall notification letter to customers informing them about the Nimbus II Plus recall and plans to replace Nimbus II Plus infusion pumps with an alternative for all patients currently on clinical service. The letter also outlined what customers can expect including:

  • The replacement will take place with a home visit to provide instruction on the new infusion pump and removal of the Nimbus II Plus infusion pump from the home.
  • A nurse will contact the patient to schedule the pump replacement, including the home visit and instructions for use of the new pump. 
  • The nurse will retrieve the Nimbus II pump and cassettes for return to the manufacturer.
  • Patients having any issues with their Nimbus II pump should contact the nurse right away to prioritize pump replacement.

The letter also included some recommended actions users should take until the Nimbus II Plus pump is replaced:

  • Only use new batteries as replacements. Take care not to confuse old and new batteries during replacement.
  • Do not cycle the battery (turn on/off) to clear an occlusion alarm. If the occlusion alarm cannot be cleared, use a new pump. Silencing the alarm does not clear the occlusion.
  • For ambulatory pump use, carry the drug product dispensing pouch in a carrying pack. Note that impeding the tubing set or placing pressure on the device (leaning against it, sitting on it) may cause it to malfunction.
  • If the patient notes any difficulties or abnormalities with the pump or accessories, immediately discontinue use of the pump and notify the Optum nurse or health care provider.

Contact Information

Customers with questions about this recall should contact Optum Homecare at 800-950-3963

Additional Resources

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using the online form or may call 1-800-332-1088 for more information on how to mail or fax the form.

 

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