BD Issues Class I Recall of Alaris System Infusion Pumps
On February 4, 2020, BD announced a recall (https://www.bd.com/en-us/support/recall-notifications/recall-notification-for-alaris-system-infusion-pumps) of all lots of affected models of its Alaris System pump modules because of multiple system errors, software errors, and use-related errors. On March 6, 2020, the U.S. Food and Drug Administration identified it as a class I recall (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=FDA%20MedWatch%20Alaris%20System%20Infusion%20Pumps%20by%20Becton%20Dickinson), its most serious level of recalls, because of the possibility of serious injuries or death.
The 774,000 affected units were distributed from July 2004–January 23, 2020, under the following models:
- BD Alaris System PC Unit Model 8000, software versions 9.5 and prior
- BD Alaris System PC Unit Model 8015, software versions 9.33 and prior and software version 12.1.0
- BD Alaris Pump Module Model 8100, software versions 9.33 and prior and software version 12.1.0.
- Alaris Syringe Module Model 8110, software versions 9.33 and prior and software version 12.1.0
- Alaris PCA Module Model 8120, software versions 9.33 and prior and software version 12.1.0
Modules with software version 9.33 or earlier may experience:
- 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 errors related to custom concentration programming
For modules with software version 12.1.0, the following issues apply:
- Low battery alarm failures
- KVO/end-of-infusion alarm priority
- Use errors related to custom concentration programming
- KVO rate not available when using delay options programming
The errors can lead to delay in infusion, interruption of infusion, slower-than-expected delivery of medication (underinfusion), and faster-than-expected delivery of medication (overinfusion). Serious adverse health events have occurred with each of the errors. Fifty-five injuries and one death were reported.
BD has contacted its customers about the affected models. Consumers with questions may reach BD at 888-562-6018, Monday–Friday from 7 am–4 pm Pacific Time, or at supportcenter@bd.com (mailto:supportcenter@bd.com).