Following a voluntary removal, the FDA deemed the recall Class I, the most serious kind, earlier this month. It affects 52,328 devices in the U.S. in total. Today, the agency shared that a slew of issues with the Nimbus infusion pump systems was related to one user death.
InfuTronix said it found 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 company also reports 3,698 complaints as a result of the issues and six serious injuries. InfuTronix won’t offer or support the devices after June 20, 2024.
Using affected pumps could cause infection from microbial contamination after loss of the sterile barrier (leakage). It could also lead to interruptions or delays in therapy. Interruptions or delays from unnoticed occlusion could lead to underdosing of vital medications and fluids. That could lead to uncontrolled hypertension (high blood pressure), dehydration and electrolyte imbalance. InfuTronix said it could also result in seizures, shock and organ failure as well. Using the Nimbus pumps may lead to serious death or injury.
The recall extends to the Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS systems.
