The FDA today warned on a Class I recall of Becton Dickinson (NYSE:BDX) Alaris system infusion pumps due to multiple system errors, software errors, and use-related errors.
All lots of five different models of the Alaris system were included in the recall that Becton Dickinson initiated on Feb. 4. In total, the company recalled 774,000 devices in the U.S. According to a news release, there have been 55 reported injuries and one death due to the issues. These were the affected models:
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- 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.
Affected Alaris PC units with the software version 9.33 and older were distributed between July 2004 and Oct. 31, 2019, while the affected PC units with the software version 12.1.0 were distributed between Dec. 18, 2019, and Jan. 23, 2020, according to an FDA release.
The modules with the software version 9.33 and older have experienced software/system errors, delay options programming, low battery alarm failures, “keep vein open” (KVO) and “end of infusion” alarm priority issues and user-related errors with custom concentration programming.
Modules with software version 12.1.0 were reported to experience low battery alarm failures, KVO and “end of infusion” alarm priority issues, custom concentration programming user errors and the KVO rate was reportedly unavailable when using delay options programming.
The errors could lead to a delay in infusion, the interruption of infusion, slower-than-expected delivery of medication and faster-than-expected delivery of medication. BD/CareFusion 303 intend to contact all affected customers to begin the scheduling process for the necessary software update when the software is made available. Without the update, affected devices may remain vulnerable to the risk of the system and software errors.
BD’s Alaris system is an infusion pump and vital signs monitoring system designed to deliver fluids, medications, blood and blood products in controlled amounts.
