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BD Alaris Systems Lawsuits

Lawyers are filing BD Alaris Systems lawsuits for people who suffered a serious injury, coma or death after receiving infusions from a faulty Alaris pump. Between 2019 and 2020, Becton, Dickinson and Company (BD) recalled millions of its BD Alaris System devices for defective software, hardware and other issues because of serious injuries and at least one death.

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The BD Alaris System is an infusion pump system that delivers fluids, medications, blood and blood products to adults, children and babies. Hospitals and health care facilities across the United States depend on these infusion pumps to deliver lifesaving fluids and medications to patients.

Infusion pumps such as those manufactured by BD often deliver high-risk medications and critical fluids, and when they fail it can lead to serious patient safety issues, according to the U.S. Food and Drug Administration.

Over the years, BD has issued several recalls for its Alaris System infusion pumps. In 2020 alone, the company issued four recalls affecting more than one million devices sold in the United States.

The FDA classified most of the 2020 recalls as class one recalls, meaning the recalled device may cause serious injuries and death.

“We stand behind the safety and clinical benefits of the Alaris System, which is used in the care of approximately 70 percent of patients undergoing infusion therapy in the U.S.,” said Ranjeet Banerjee, BD Worldwide President, Medication Management Solutions in a Feb. 14, 2020 customer letter.

Reasons for Recall

BD issued recalls of its 8000 series infusion pumps for various hardware, software and user-related errors. BD said these errors could lead to over and under infusion, interruption of infusion and infusion delay.

High-risk patients receiving life-saving medications have the greatest risk of harm from delays or interruption of infusion. Problems with infusion could even lead to death for these patients, BD said in its Aug. 4, 2020 Urgent Medical Device Recall letter for its BD Alaris PC Unit Model 8015 PC Unit Front Case with Keypad Replacement Kits.

“For some hospitals, it could be a financial issue (to not replace the pumps) and then a quality issue,” Joseph Spallina, a health care consultant with Arvina Group LLC, told Crains. “This is a very serious recall, no doubt about it. The facts are the FDA said using these devices can cause serious injury or death to patients.”

A BD spokesperson told Crains that even though the company issued a voluntary recall, “a recall doesn’t mean that devices have to be returned or stop being used.”

Reasons for recalls include:
  • Software and system errors (class one recall)
  • Alarm failures for low battery and “end of infusion” (class one recall)
  • Use-related errors (class one recall)
  • Delay options programming (class one recall)
  • Damaged inter-unit interface (IUI) connectors (class one recall)
  • Broken elements on module platen (class one recall)
  • Improperly secured PCU battery (class one recall)
  • Dim LED segment(s) on modules (class two recall)

At the time of the recalls, BD was aware of 55 reported injuries and one death.

It also reported 1,186 complaints related to its Alaris PC Unit Model 8015. The company recalled the devices because one or more keys on the keypad could become stuck or unresponsive. This could prevent clinicians from changing medication or fluid infusions and infusion delay.

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Recalled Models

The FDA classified problems with the recalled pumps as class one or two recalls. All of the recalled pumps had an issue classified as class one and most had secondary issues classified as class two recalls.

Recalled Alaris System models:
  • BD Alaris PC Unit Model 8000
  • Alaris PC Unit Model 8015 Front Case with Keypad Replacement Kits
  • BD Alaris Pump Module 8100 Front Case with Keypad Replacement Kits
  • BD Alaris Syringe Module 8110
  • BD Alaris PCA Module Model 8120
  • BD Alaris EtCO2 Module Model 8300
  • BD Alaris SpO2 Module Model 8210 and Model 8220
  • BD Alaris Auto ID Module Model 8600

Individual and Class Action Lawsuits

Individual injury lawsuits for the BD Alaris system are still in initial stages. Lawyers are reviewing cases from patients or patients’ families for serious injuries, coma and death because of faulty infusion pumps.

But on Feb. 27, 2020, BD’s investors filed a class action lawsuit against the device maker. In February 2020, BD disclosed that it had lost $59 million in connection with the recent recall of some pumps and stock prices fell, according to a press release by lawyers representing investors.

The complaint alleges that BD failed to tell investors that the pumps experienced software errors and alarm issues and was investing in remediation efforts instead of a software upgrade to fix problems. As a result of these problems, BD’s positive projections about its business were misleading.

Infusion Pump
BD Alaris Systems Lawsuit Facts
  1. Manufacturer Becton, Dickinson and Company
  2. Injuries Serious injuries, including coma and death
  3. Status Initial stages, no trials scheduled or settlements

Please seek the advice of a medical professional before making health care decisions.

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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 nearly a decade. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and women’s health issues. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • Member of American Medical Writers Association (AMWA) and former 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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12 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. BD. (2020, August 4). URGENT: Medical Device Recall BD Alaris PC Unit Model 8015 PC Unit Front Case with Keypad Replacement Kits. Retrieved from https://www.bd.com/en-us/support/recall-notifications/recall-notification-bd-alaris-pc-unit-model-8015
  2. BD. (2020, February 14). Valued BD Alaris System Customer. Retrieved from https://www.bd.com/documents/alerts/CustomerLetter_AlarisDistribution_2-14.pdf
  3. BD. (2020, March 12). Valued BD Alaris System Customer. Retrieved from https://www.bd.com/documents/alerts/CustomerLetter_AlarisMedicalNecessity_3-12.pdf
  4. BD. (n.d.). Infusion system devices. Retrieved from https://www.bd.com/en-us/offerings/capabilities/infusion-therapy/infusion-system-devices
  5. Bragar, Eagel & Squire. (2020, February 27). Becton, Dickinson And Company Alert: Bragar Eagel & Squire, P.C. Announces That a Class Action Lawsuit Has Been Filed Against Becton, Dickinson and Company and Encourages Investors to Contact the Firm. Retrieved from https://apnews.com/press-release/pr-businesswire/be51af9a658e4e04a858a30c2a6312de
  6. Greene, J. (2020, September 25). Infusion pump recall has hospitals scrambling whether to replace, repair them. Retrieved from https://www.crainsdetroit.com/health-care/infusion-pump-recall-has-hospitals-scrambling-whether-replace-repair-them
  7. Med One Group. (2019, March 7). Alaris 8100 Pump Module Pump Training. Retrieved from https://www.youtube.com/watch?v=Fyth0syNTP4
  8. U.S. Food and Drug Administration. (2018, August 22). Infusion Pumps. Retrieved from https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/infusion-pumps
  9. U.S. Food and Drug Administration. (2019, July 18). Becton Dickinson (BD) Recalls Alaris Infusion Sets for the Alaris Pump Model 8100 Due to Potential for Tube Collapse that May Cause Unintended Delivery or Faster than Expected Delivery of Medication. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/becton-dickinson-bd-recalls-alaris-infusion-sets-alaris-pump-model-8100-due-potential-tube-collapse
  10. 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
  11. U.S. Food and Drug Administration. (2020, September 1). BD Provides Update on Previously Disclosed Recall of BD Alaris System Hardware. Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-provides-update-previously-disclosed-recall-bd-alaris-system-hardware
  12. U.S. Food and Drug Administration. (2020, September 14). Becton Dickinson (BD) CareFusion 303, Inc. Recalls Alaris System PC Unit and PC Unit Front Case Keypad Replacement Kits Due to Risk of Stuck or Unresponsive Keys. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/becton-dickinson-bd-carefusion-303-inc-recalls-alaristm-system-pc-unit-and-pc-unit-front-case-keypad
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