Electronic infusion pumps that deliver controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural and other routes of administration are being pulled from the market after the Food and Drug Administration (FDA) issued a Class 1 recall on the products. A Class 1 recall is the most serious type of recall and involves situations in which there is reasonable probability that the use of the products will cause serious injury or death.
The recall includes various modules of Cardinal Health’s Alaris System products that are intended for use with both adult and pediatric patients in hospitals including critical care units, emergency rooms, outpatient surgical centers, hospices and nursing homes. The firm initiated the recall after identifying five problems that affected the Alaris System, including failure of the occlusion warning message, syringe volume warning message, electrostatic discharge protection circuitry and fluid ingress tubing. Those five failures may result in patients experiencing under- or over-infusion which may result in serious injury or death.
Products that fall under the Class 1 recall are the Alaris Point-of-Care (PC) Unit (Model 8000 and 8015) (formerly Medley PC unit), Occlusion Warning Message for Alaris Pump Module, Syringe Volume Warning Message for Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module), Electrostatic Discharge (ESD) Protection Circuitry, Alaris Pump Module (Model 8100) (formerly Medley Pump Module) – Direct for Use (DFU) update, Fluid Ingress (fluid entering the pumping mechanism), Alaris System (Formerly Medley System) – DFU Update, and the IUI (Inter-Unit Interface) Connectors.
Customers may contact Cardinal Health at 888-562-6018 with any questions. Patients or healthcare professionals are urged to report any adverse events associated with use of the products to the FDA MedWatch Reporting Program.