OptumHealth Care Solutions has recalled the Nimbus II Plus Ambulatory Infusion System for products distributed between August 19, 2020 and April 20, 2024. The FDA, who identified this as a Class I recall, has the press release.
The device is used to “deliver medications and/or fluids to a patient under the direction or supervision of a doctor or other certified health care professional. These devices are used for infusions under the skin (subcutaneous), in the spaces between nerves (perineural or epidural), or into blood vessels (intravenous). The pumps are sometimes used for patients to deliver their own pain medications (patient-controlled analgesia or PCA).”
The infusion pumps are being recalled 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.” Using pumps affected by the recall could lead to “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. Use of these products may lead to serious injury or death.”
There have been no additional injuries or deaths since an InfuTronix recall of these devices back in February of 2024. OptumHealth Care Solutions plans to “replace Nimbus II Plus infusion pumps with an alternative for all patients currently on clinical service.”
