FDA Announces Class I Recall of Alaris Infusion Pump Module Model 8100 Bezel

On August 24, 2021, the FDA announced that Bio-Medical Equipment Service Co. is recalling several of its Alaris Infusion Pump Module Model 8100 Bezels due to reports of bezel repair posts cracking or separating. The bezel is a critical component in the process of delivering fluids to the patient. If the bezel components crack or separate, the patients may be delivered too much or too little of the intended fluid which may lead to serious injury or death.

The BD Carefusion Alaris Infusion Pump Module Model 8100s are devices that, when working as intended, reliably deliver large volumes of blood, blood products, prescription drugs, and other fluids into a patient’s body in a slowed, controlled manner. Infusion pumps are typically used in clinical settings such as hospitals, but may also be found in nursing homes and other assisted-living communities. The Alaris infusion pumps are designed to be set into a patient’s vein or other administration route. The patients rely on the infusion pumps for accurate delivery of fluids. Unfortunately, the pump’s bezels have been found to crack or separate. According to the FDA announcement, the cracking or separation of the bezel component can result in the free flow of fluids, over- or under-delivery of fluids, and the interruption of fluid delivery to the patient. The device may also lose power or begin leaking, burning or smoking. Because of the severity of the injuries associated with the cracked bezel problem, the FDA has identified the recall as a Class I recall, its most serious designation.

Bio-Medical Equipment Service Co.’s recall is just the latest in a string of 2021 recalls involving Alaris infusion pump bezels. Indeed, on March 24, 2021, Pacific Medical Group – doing business as Avante Health Solutions – recalled 2,452 bezels after a death resulted potentially related to a cracked bezel. Infusion Pump Repair, Tenacore and Step-Har Medical also recalled Alaris infusion pump bezels they purchased and/or installed.

If you or a loved one has suffered serious injuries or died and you suspect this could be attributed to an interruption of the delivery of fluids or medication during an infusion, contact Burg Simpson’s award-winning Cincinnati product liability attorneys today. Our experienced lineup of lawyers has successfully represented thousands of individuals who have been injured by defective products. We are here to help you. Call 513-852-5600 or fill out our contact form for a FREE no-obligation consultation today.