Several Potential Failure Points Leads to OptumHealth Infusion Pump Class I Recall

OptumHealth Care Solutions has recalled its Nimbus II Plus infusion pumps — a recall now deemed Class I by the FDA — because of the potential for the device to fail from a variety of issues.

Battery failure, occlusion, system errors, drug product leakage, high or low flow rate, or damaged housing are the potential issues that could cause the device to fail, the FDA announced.

According to the agency, the affected pumps could cause infection from loss of the sterile barrier, underdosing of vital medications and fluids, dangerous changes in blood pressure, dehydration, and electrolyte imbalance. Seizures, shock and organ failure may also occur. Use of these products may lead to serious injury or death.

The devices will not be available or supported after June 20.

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