The company advises taking any dropped or severely jarred modules out of service and sending them to biomedical engineering for inspection before reuse.
Becton Dickinson (BD), a subsidiary of CareFusion 303 Inc, has issued a letter to affected customers recommending users take additional precautions with Alaris Pump Modules that have been dropped or severely jarred.
Dropping the Alaris Pump Module may cause damage to internal components that may not be apparent or readily visible, such as damage to the Alaris Pump module bezel assembly, which provides the mechanical foundation for critical pumping components. This damage can cause under-infusion, over-infusion, unregulated flow, or failure of the Alaris Pump module to calibrate.
Over and under infusions can potentially lead to serious adverse health consequences including serious injury and death, depending on the type of drug (and its resulting clinical effect), the patient criticality and magnitude of the flow rate inaccuracy.
As of Sept 22, 2025, BD has reported two serious injuries and no deaths associated with this issue.
What to Do
On Oct 17, BD sent affected customers a letter recommending not to use a device that has been dropped or severely jarred. Devices that have been dropped or severely jarred should be segregated and sent to biomedical engineering for inspection, as directed in the “Summary of Warnings and Cautions” section of the BD Alaris Infusion System with Guardrails Suite MX User Manual: “If a device or accessory is dropped or severely jarred, take the device out of use immediately. Send the device to biomedical engineering for inspection to ensure the device is functioning properly before reuse.”
The BD Alaris Infusion System with Guardrails Suite MX User Manual can be accessed via the service and support portal.
Prior to use, BD instructs customers to inspect the Alaris Pump Module for visual damage. If the device has physical damage, remove from service and send to biomedical engineering for further inspection and testing, as directed in the BD Alaris Infusion System User Manual: “To ensure that the BD Alaris Infusion System remains in good operating condition, visually inspect the system before each use. Check all visible surfaces and moving parts on the devices. If you observe damage in any way or find the device does not function as expected, return it to biomedical engineering for repair.”
BD also instructs customers to use only BD-authorized companies when renting the BD Alaris System (eg, Agiliti, Med One Group, US Med-Equip). BD-authorized companies are trained in proper device management and handling.
A list of affected devices can be found on the FDA’s website.
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