FDA announces class 1 recalls for infusion pumps, anesthesia workstation

Editor's Note

Reports of spontaneous backup battery failure in Dreager Inc.’s Perseus A500 anesthesia workstation and multiple failures in InfuTronix, LLC’s Nimbus infusion pump systems prompted the FDA to classify manufacturer recalls as class 1, the most serious categorization indicating risk of serious harm or death.

According to an April 25 FDA announcement, reports of the anesthesia system’s internal, backup battery failing without generating an alarm could lead to hypoventilation or hypoxia. Although four incidents have been reported so far, none resulted in injury or death. In an urgent recall notice issued on March 10, the manufacturer recommended affected parties test all device batteries, return devices that fail the test, and complete the verification form included with the letter.

Also posted April 25, the FDA report on the Nimbus infusion pump system recall cites concerns about potential failure modes including battery failure, upstream blockage (occlusion), system errors, drug product leakage, high or low flow rate, or damaged housings. Risks to patients infection due to loss of the sterile barrier (leakage); unnoticed occlusion leading to under-dosing medications and subsequent hypertension, dehydration, and electrolyte imbalance; and seizures, shock, and organ failure.

So far, the manufacturer reports 3,698 complaints, six serious injuries, and one death. On February 21, the manufacturer sent customers an Urgent Medical Device Removal letter informing them that the pump systems are being removed from the market and will no longer supported after June 20. Customers are recommended to seek alternative infusion methods and contact InfuTronix customer service to return the affected pump systems.

Other recent class 1 FDA recalls involve dialysis systems: Tablo hemodialysis devices and Fresenius Stay-Safe catheter extension sets and Stay-Safe Luer Lock adapters.