The FDA announced May 30 that OptumHealth Care Solutions is recalling 208 infusion pump systems.
The product, called the Optum Nimbus II Plus Ambulatory Infusion System — sometimes called the Nimbus II – Optum Homecare Infusion — is part of a Class I recall, the most serious type, which, according to the FDA, "use of these devices may cause serious injuries or death."
Related devices including the Nimbus Administration Set, Flex, and PainPro/Halo Ambulatory Infusion System, as well as Nimbus II PainPRO, Flex, Plus, EpiD, and EMS were part of a similar 52,000 product, Class I recall in late April.
OptumHealth's recall of its Nimbus II Plus Ambulatory Infusion System is in response to medical devicemaker InfuTronix's recall of the 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 FDA alert states.
Using the 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," according to the FDA.
No additional injuries or deaths have been reported outside of the initial ones reported, which prompted the April InfuTronix recall.
"The device at issue is not originally manufactured by Optum, and we are complying with FDA requirements related to this matter," a spokesperson for the company told Becker's. "Optum is unaware at this time of any report of injury or harm from our patient population related to this device."
None of the devices will be available or supported after June 20, 2024.