Recall Information

FDA

The Alaris System is an infusion pump and vital signs monitoring system. The infusion pumps deliver fluids, medications, blood and blood products into a patient’s body in controlled amounts. The pump provides fluids through an infusion tubing set into a patient’s vein or through other cleared routes of administration. The system is used in adult, pediatric and neonatal care. The device is used in hospitals and other healthcare facilities.

BD/CareFusion 303 is recalling the Alaris Infusion Pump System and Modules due to multiple system errors, software errors, and use-related errors.

For modules with software version 9.33 or earlier, the following issues apply:

• Software/System errors (System Error 255-xx-xxx)
• Delay options programming
• Low battery alarm failures
• Keep vein open (KVO) / “End of Infusion” alarm priority
• Use-related errors related to custom concentration programming

For modules with software version 12.1.0, the following issues apply:

• Low battery alarm failures
• Keep vein open (KVO)/ “End of Infusion” alarm priority
• Use errors related to custom concentration programming
• KVO Rate Not Available When Using Delay Options programming

These errors can lead to delay in infusion, interruption of infusion, slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion).

For more information, visit FDA: https://www.fda.gov/medical-devices/medical-device-recalls/becton-dickinson-bd-carefusion-303-inc-recalls-alaris-system-infusion-pumps-due-software-and-system?utm_campaign=2020-03-06%20Alaris%20Infusion%20Pumps%20Recalled%20Due%20to%20Software%20Errors%20and%20Use%20Errors&utm_medium=email&utm_source=Eloqua