The Food and Drug Administration (FDA) is reporting on recalls of several models of Alaris System Infusion Pumps (BD/CareFusion 303).
The Alaris System is an infusion pump and vital signs monitoring system delivers fluids, medications, blood and blood products into a patient’s body in controlled amounts. The device is used in hospitals and other healthcare facilities in adult, pediatric, and neonatal care. Several models of the Alaris System are affected by the recall due to at least 1 of 4 possible situations:
Situation 1: Damaged Inter-Unit Interface (IUI) connectors
Situation 2: Broken elements on Alaris Pump Module platen
Situation 3: Improperly secured PC unit battery
Situation 4: Dim Segment
The FDA has identified the occurrence of Situations 1, 2 and 3 as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. There have been serious injuries and deaths reported when Situation 1, 2, or 3 occurred. The FDA has identified the occurrence of Situation 4 as a Class II recall, use of these devices may cause temporary or medically reversible injury.
Food and Drug Administration (FDA). Becton Dickinson (BD) CareFusion 303 Recalls Alaris System Infusion Pumps Due to Damaged Inter-Unit Interface Connectors, Loose or Missing Battery Screws and A Broken Upper and Lower Hinge Posts and Membrane Frame [news release]. September 14, 2020. Available at: click here. Accessed September 15, 2020.