Thousands of Infusion Pumps Recalled After Several Injuries and a Death
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On March 6, 2020, the U.S. Food and Drug Administration announced that it had classified the Becton Dickinson Alaris System infusion pump recall as a Class I recall, the agency’s most severe recall for medical devices that could cause serious injury or death.
The Alaris System is a vital signs monitoring system and infusion pump that delivers medications, fluids, blood products and blood to patients in set amounts. Healthcare facilities and hospitals use the device for adults, children and infants.
The device’s maker — Becton, Dickinson and Company (BD) and its subsidiary CareFusion 303 Inc. — recalled all lots of the pumps on Feb. 4 because of software errors, multiple system errors and use-related errors. The recall affects 774,000 units sold in the United States.
These errors have caused serious adverse events. At the time of the FDA’s recall notice, there were 55 reported injuries and one death.
What Are the Problems?
According to the FDA’s notice, Alaris Pump models included in the February 2020 recall have errors that may lead to interruption of infusion, delay in infusion, slower medication delivery (under-infusion) and faster medication delivery (over-infusion).
“High risk patient populations who are receiving life sustaining infusions are at the greatest risk of harm. For these patients, stopping or significantly lowering the infusion rate can lead to serious injury or death,” Becton, Dickinson and Company said in its Feb. 4 recall notification to customers.
Device issues for recalled models with software version 9.33 or earlier are:
- Custom concentration programming use errors
- Failures in the low battery alarm
- Keep vein open (KVO) / “End of Infusion” alarm priority
- Problems with delay options programming
- Software/system errors, specifically error 255-xx-xxx
Device issues for recalled models with software version 12.1.0 are:
- Custom concentration programming use errors
- Failures in the low battery alarm
- Keep vein open (KVO) / “End of Infusion” alarm priority
- When using delay options programming the KVO rate is not available
Models Included in Recall
Five different models of the Alaris system are affected by the February 2020 recall. All lots of these models are included in the recall.
Recalled Alaris Pump models are:
- 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.
This is not the first time these pumps have been recalled. A search of the FDA’s medical device recall database showed at least 22 recalls for the Alaris Pump from June 2008 to March 2020. The FDA classified at least 10 of those recalls as Class I.