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Thousands of Infusion Pumps Recalled After Several Injuries and a Death

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Patient using IV drip

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.

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
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3 Cited Research Articles

Drugwatch.com writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. Becton, Dickinson and Company. (2020, February 4). URGENT: Medical Device Recall Notification AFFECTED DEVICE: BD Alaris System. Retrieved from https://www.bd.com/documents/alerts/AlarisSystem9.x_CustomerRecallPackage.pdf
  2. U.S. Food and Drug Administration. (2018, September 26). Medical Device Recalls. Retrieved from https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
  3. U.S. Food and Drug Administration. (2020, March, 6). Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/becton-dickinson-bd-carefusion-303-inc-recalls-alaris-system-infusion-pumps-due-software-and-system
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