News & Press: Patient Safety

Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps

Wednesday, March 11, 2020  
SIS Patient Safety Alert 03/11/2020: Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither SIS nor the FDA endorse either the product or the company.

ISSUE: 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).

There have been serious adverse health events with each of these errors. There are 55 reported injuries and one death.

RECOMMENDATION:
  •  Consumers with Alaris System Infusion Pumps System Software 9.33 and earlier should follow the specific recommendations to help mitigate the potential risk of errors until the software issues have been remediated (BD/CareFusion 303 Recall Notice Webpage)
  • Consumers with Alaris System Infusion Pumps System Software 12.1.0 should follow the specific recommendations to help mitigate the potential risk of error until the software issues have been remediated (BD/CareFusion 303 Recall Notice Webpage)


Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Source: Food and Drug Administration - Accessed 03/11/2020


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