InfuTronix, LLC announced a voluntary recall of the Nimbus Ambulatory Infusion Pump System, including Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD, and Nimbus II EMS.

The recall was due to a high number (3,698) of customer complaints related to the Nimbus Infusion Pump systems dating from May 2019 to August 2023. An evaluation of complaint data identified several potential product issues:

  • Battery Power may potentially affect the performance of the pump by causing an immediate power off event.
  • Upstream Occlusion, as noted by the upstream occlusion alarm, occurs when there is a block in flow of the proximal end of the administration set.
  • System Errors, as noted by the System Error alarm which causes the pump to suspend the infusion.
  • Drug product egress from certain administration set bonding points, which may potentially result in drug product leaking from the device.
  • Flow Rate (high or low) which may potentially lead to the pump infusing an inaccurate delivery of the drug.
  • Pump Housing design which may potentially result in damage over time to certain areas of the housing responsible for administration set engagement, leading to false occlusions and flow rate inaccuracies.

Nimbus Infusion Pump Corrective Actions

InfuTronix determined that the best way to address the identified product issues and potential outcomes is a redesign of the Nimbus Infusion Pump system.

The redesign will allow InfuTronix to improve several aspects of the product including mechanics, electronics, software, and housing design as well as aspects of the administration set. Given the number of anticipated design improvements and the extensive requirement for design, verification, and validation, InfuTronix believes a new premarket notification(s) and clearance from FDA may be required.

As a result, InfuTronix is seeking to remove the system from the market while these improvements and design changes are being made and a new clearance is obtained.

An independent evaluation has determined that the common device failure modes pose a low risk to users.

Recommendations for Continued Usage

Users may continue to use the Nimbus Infusion Pump system and associated infusion sets during this removal process. Users should be aware of the signs indicating a potential issue with the pump (How to recognize that a device may fail):

  • Battery – The infusion pump will brown out (fail-safe). The user will see that the pump has shut off. Additionally, the LED screen may flicker prior to failure, indicating a potential battery issue.
  • Upstream Occlusion – Auditory and visual occlusion alarm alerts the user of the occlusion.
  • System Error – Auditory and visual system error alarm will alert the user.
  • Drug Product Egress – The user may notice leaking drug from the pump pouch or infusion set or feel wetness from the drug product.
  • Flow Rate (high/low) – Auditory and visual occlusion alarm for low flow will alert the user of occlusion. The user will notice residual volume remaining at the end of therapy. High flow rate may be associated with shortened infusion times.
  • Pump Housing Damage – The user may notice broken latches, hinges, or cracks in the housing and/or user may notice that the device is difficult to assemble prior to use.

Infutronix has already notified customers with a letter that details the products impacted, reason for the voluntary removal, risk to health assessment, how to recognize the device may fail and actions to be taken by the customer/user.