Summary: OptumHealth Care Solutions is recalling Nimbus II Plus infusion pumps due to multiple failure modes, following an InfuTronix recall. The FDA has classified it as a Class I recall. Optum is replacing affected pumps and has issued guidelines for current users.

Key Takeaways:

  • Recall Reason: Nimbus II Plus infusion pumps are recalled due to battery failure, occlusion, system errors, leakage, flow rate issues, and damaged housing.
  • User Guidelines: Users should replace old batteries, avoid cycling the battery for alarms, carry the dispensing pouch properly, and report any issues immediately.

OptumHealth Care Solutions is recalling Nimbus II Plus infusion pumps (also known as the Nimbus II – Optum Homecare Infusion) in direct response to the previous 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.

Potential Risks of Affected Pumps

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.

No Additional Injuries Reported

OptumHealth Care Solutions reports no additional injuries or deaths related to this issue beyond those in the original InfuTronix recall. The FDA identified it as a Class I recall, the most serious type of recall, meaning that use of these devices may cause serious injuries or death.

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

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 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.

Device Description

The Optum Nimbus II Plus (also known as the Nimbus II – Optum Homecare Infusion), is an ambulatory infusion pump system. These devices are used for infusions under the skin, in the spaces between nerves, or into blood vessels. The pumps are sometimes used for patients to deliver their own pain medications. Nimbus infusion pump systems are used in hospitals, other healthcare facilities, and in nonclinical environments such as patient homes.