Dive Brief:
- Infutronix is removing its Nimbus Infusion Pump Systems from the market after receiving nearly 3,700 complaints.
- The Food and Drug Administration, which posted the Class I recall in its database last week, said the action affects more than 52,000 medical devices distributed in the U.S.
- Infutronix listed six issues that can cause the pumps to stop infusions and otherwise malfunction in its statement. The company will stop supporting the devices after June 20.
Dive Insight:
Infutronix began distributing the pumps in the U.S. in 2014. Postmarket surveillance identified problems with the devices. From May 2019 to August 2023, users sent nearly 3,700 complaints about faults that can cause the pumps to switch off, suspend infusions, leak drug product and administer the wrong amount of medicine.
The company concluded that it needs to redesign the system “to improve several aspects of the product including mechanics, electronics, software, and housing design as well as aspects of the administration set.”
Based on the number of anticipated design improvements and “the extensive requirement for design, verification and validation,” Infutronix has determined that a new premarket notification and clearance from the FDA may be required. That conclusion led the company to start removing the current device from the market while it works to make the changes and secure regulatory clearance for the updated pump.
Infutronix encouraged healthcare providers to seek alternative methods of drug product infusion “at the earliest possible opportunity.” The company has created a process for returning the Nimbus systems.
Healthcare providers can continue to use the pumps during the removal period. Infutronix advised people who continue to use the devices to be aware of signs indicating a potential issue with the pump, including alarms, flickering screens and leaks.
A health hazard evaluation performed by an independent physician determined that the common device failure modes pose a low risk to users, according to the company.