Everything You Need to Know About BD Alaris Remediation

Nearly five years after Becton Dickinson (BD) issued a voluntary recall of the Alaris Infusion System, ongoing software issues continue to impact the safety and reliability of Alaris infusion pumps. The initial recall affected approximately 774,000 devices across the United States. Since 2020, BD has issued multiple Class I recalls for additional Alaris System issues, including some replacement parts, cybersecurity gaps, and keypad malfunctions.

Affected infusion devices have the potential to increase patient risk significantly and may cause frustrating disruptions to clinician workflows, reducing both efficiency and care quality. Therefore, these devices require close attention from hospitals and biomedical equipment technicians (BMETs).

As the situation evolves, BMETs servicing Alaris infusion pumps need access to up-to-date, trustworthy information. A well-informed action plan for remediation ensures Alaris devices will function safely and effectively on hospital floors. We’ve compiled these essential facts, timelines, and recommendations to help BMETs and hospitals successfully manage the Alaris recall.

Why did BD recall the Alaris Infusion Pump System?

BD issued the voluntary recall after identifying software anomalies that led to pump errors and malfunctions. Some of these include:

• System code errors: inaccurate system error codes that could lead to medication interruption or delay, potentially causing pump shutdown.
• Delay function issues: interference with the delay option programming (which lets users program a delayed start to an infusion), potentially leading to timing errors such as late medication delivery.
• Low battery alarm failures: in the event the alarm fails to notify staff of low battery power, the device could run out of power without warning, aborting medication delivery.
• Keep vein open (KVO) alarm: misprioritization of these alarms, which notify staff that the pump has switched to KVO, a function in which a small amount of fluid is delivered to keep the patient’s vein open, can delay notifications, resulting in under-dosing or missed doses.
• Customer concentrations programming: this software issue can cause inaccuracies in medication concentration, potentially creating dosing errors.

At the time of the 2020 recall, the FDA reported 55 injuries and one death related to the BD Alaris infusion pump recall.

What was the timeline of the recall?

BD issued the 2020 Alaris System recall primarily in response to Medical Device Reporting (MDR) submissions highlighting recurring software problems.

Key events timeline:

February 4, 2020

BD initiates a voluntary recall of the BD Alaris System. In a customer letter, BD explains the concerning issues, offers mitigation steps for clinicians, and announces plans for a software update to remediate the software problems.

June 30, 2020

BD announces another Class I voluntary recall regarding hardware issues that could result in pump malfunction.

August 4, 2020

Four more recalls pertaining to the Alaris System are issued by BD, three of which the FDA designated as Class I.

April 26, 2021

BD files a 501(k) submission with the FDA for the BD Alaris Infusion System. The submission covers the latest software version 12.1.2 and various hardware updates, designed to address the issues related to the February 2020 recall and subsequent recalls.

July 29, 2021

Remediation begins for devices impacted by the February 2020 recall via the new software version.

July 21, 2023

The FDA grants 510(k) clearance for the updated BD Alaris Infusion System, covering “updated hardware features for Point-of-Care Unit (PCU), large volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring and auto-identification modules,” as well as a new software version with cybersecurity and interoperability enhancements.

The clearance enables BD to resume distribution and engage in comprehensive remediation efforts.

What is the current state of the recall?

BD has resumed full commercial activities for the BD Alaris Infusion System while continuing to address ongoing concerns through remediation and replacement. In a 2023 news release, BD stated that “​​all of the current Alaris devices in the U.S. market will be remediated or replaced with the updated 510(k) cleared version.” This version also addresses issues from the additional recalls via cybersecurity improvements and hardware upgrades.

Hospitals can collaborate directly with BD to schedule and execute the remediation or replacement of Alaris devices. Contact information is available on the company’s support page.

How can hospitals prepare for the remediation process?

Being prepared for the remediation of IV pumps helps ensure a smooth process, reduce downtime, and minimize care interruptions. Careful planning and close collaboration with the assigned BD remediation team is essential to complete updates or replacements in compliance with FDA guidance.

Here are some essential questions for hospitals and technicians to consider:

What is the remediation timeline?

Understanding the timeline helps reduce unexpected setbacks. Discuss the estimated timing for software updates, hardware replacements, and other necessary changes with collaborators in detail.

Will the facility receive new devices?

Whether the remediation requires new Alaris infusion pumps depends on the facility’s current equipment profile. Older devices may need to be replaced, so it’s important to clarify the specifics around receiving new assets.

Can repairs be performed in-house?

BD must perform all recall-related activities. While some patches or repairs may be possible to conduct on-site, it’s not recommended that hospitals or BMETs undertake any recall-related modifications on their own. Unauthorized adjustments to Alaris pumps could void regulatory compliance and potentially exacerbate patient safety risks.

How will remediation impact daily operations?

Consider whether devices will be offline or unavailable during the process so alternative devices or temporary staff protocols can be in place before remediation begins.

Remember to keep communication lines open

The remediation process can feel overwhelming, as it requires clarity around issues and adjustments for multiple functionalities and components. Being proactive about communication between hospital staff and the BD team helps make the process run smoothly and ensures any concerns that arise before, during, and after remediation are addressed promptly. Although Elite Biomedical Solutions isn’t authorized to perform remediation services, we’re available to assist BMETs with clarifications and recommendations based on our expertise with the Alaris Infusion System.

Elite Biomedical Solutions manufactures OEM quality replacement components for infusion pumps and telemetry devices. Please contact us for more information about Elite’s exceptional parts, expert repair support, or customized BMET courses.