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Overview

Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors

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

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