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John R. Fischer, Senior Reporter | March 26, 2024
Nimbus II Flex (Photo courtesy of Intuvie)
Several identified potential risks have led to the recall of an InfuTronix infusion pump that has been on the market for nearly a decade, with the company saying it will redesign the solution to address these issues.
According to a company notice, InfuTronix’s Nimbus Ambulatory Infusion Pump family is only sold in the U.S. and has been on the market since October 2014. Versions include the Nimbus Ambulatory Infusion Pump, Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD, and Nimbus II EMS. InfuTronix is a subsidiary of Intuvie, a provider of infusion solutions.
Between 2019 and 2023, a high number of complaints were reported to the FDA about these products, with the most common being the device turning off due to battery performance, a block in the flow of the proximal end of the administration set leading to upstream occlusion, and system errors suspending infusion. Also, drug product egress from certain administration set bonding points was found to cause pharmaceutical leaks from the device; high or low flow rates led to inaccurate dosing; and damage over time to the pump housing design risked causing false occlusions and flow rate inaccuracies.
“InfuTronix has determined that the best corrective and preventive action to address the identified product issues and potential outcomes is a redesign of the Nimbus Infusion Pump system. The redesign of the system 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,” said InfuTronix in a statement.
An independent physician performed a health hazard evaluation on routine postmarket complaint failure modes and found that those associated with the pumps posed a low risk to users.
Because of the number of expected design improvements and requirements in the development, verification, and validation processes, InfuTronix expects that it may need to again seek premarket notifications and clearance from the FDA. As a result, the device will no longer be available for sale or supported after June 20.
The company has already notified patients via letter and says that while it is safe to continue using the device during the removal process, users should keep an eye out for signs that indicate any of the potential risks found in the review or others.
Healthcare providers should also read the instructions for use and educate patients on recognizing audial and visual alarms and inspecting devices for damage. Because the solution will no longer be available after June 20, the company highly encourages providers to seek alternative methods for drug product infusion as early as possible.
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