BD Expands Critical Recall of Alaris Pump Module: Patient Safety at High Risk

Becton, Dickinson and Co. (NYSE:BDX), a leading global medical technology company, has significantly expanded its recall of the Alaris Pump Module (Model 8100), a device widely used in healthcare settings for administering critical medications and fluids. This latest action marks a continuation of ongoing efforts to address serious software-related issues that pose a significant risk of patient harm, including serious injury or even death.

The U.S.

Food and Drug Administration (FDA) has classified this as a Class I recall, the most serious type, indicating that there is a reasonable probability that the use of these devices will cause serious adverse health consequences or death. The expanded recall specifically targets Alaris Pump Modules running software versions 9.33, 12.1.2, and 12.1.3.

The core problem stems from persistent software anomalies and system errors that can lead to hazardous scenarios during infusion therapy.

These include unexpected infusion interruptions, incorrect infusion rates, and premature battery depletion. Such malfunctions can result in delays in critical patient therapy, under-infusion, or over-infusion, all of which can have severe, life-threatening implications for patients, particularly those requiring precise medication dosages or continuous life support.

BD initially initiated a recall related to Alaris systems in 2020, followed by a further expansion in 2021.

This latest expansion in 2024 underscores the complexity and gravity of the underlying issues, highlighting the continuous challenges in ensuring the safety and reliability of these essential medical devices. The company has been under increased scrutiny from the FDA regarding its Alaris infusion systems, with several warnings and recalls issued over recent years for various components and software versions.

In response to this expanded recall, BD has issued updated recommendations to healthcare providers.

These guidelines emphasize the critical need for continuous monitoring of patients receiving infusions via the Alaris Pump Module. Healthcare facilities are advised to promptly address any system errors or unexpected device behavior, which may include discontinuing use of the affected module and switching to alternative infusion methods.

BD is also working with affected customers to provide necessary software updates and support.

This ongoing situation serves as a stark reminder of the paramount importance of medical device safety and the rigorous oversight required to protect patient well-being. Healthcare providers are urged to review the specific details of the expanded recall provided by BD and the FDA to ensure full compliance and mitigate any potential risks to their patients.