This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.    

Affected Product

The FDA is aware that 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. 

What to Do

Do not use a device that has been dropped or severely jarred. Devices that have been dropped or severely jarred should be removed from use immediately and thoroughly tested and inspected by qualified service personnel in accordance with the instructions for use prior to reuse.

On October 17, BD sent all affected customers a letter recommending the following actions:

• Customers should NOT 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 at https://bd.com/self-service. 
• Prior to use, 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.”
• Distribute this notice within your facilities and ensure that both clinical and non-clinical users (e.g., environmental services and transport staff) are trained to remove any dropped or severely jarred devices from use and sequester the device for inspection and testing. Ensure all relevant personnel receive a copy of the BD Alaris Infusion System Inspection Safety Reminder. Tip sheets can be accessed via the BD Learning Academy at https://academy.bd.com/en-us/home. 
• Provide this notice to any facilities you may have sold or transferred devices to. 
• Use only BD-authorized companies when renting the BD Alaris System (e.g. Agiliti, Med One Group, US Med-Equip). BD-authorized companies are trained in proper device management and handling. 
• Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification.

Reason for Correction

BD stated that dropping the Alaris Pump Module may cause damage to internal components that may not be apparent or readily visible. More specifically, drops or severe jarring may damage 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.

Damage to the pumping mechanism may prevent the device from delivering an accurate amount of fluid flow through the pumping cycle resulting in an over or under infusion condition. 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 September 22, BD has reported two serious injuries, and no deaths associated with this issue.

Device Use

The BD Alaris System is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces.

Contact Information

Customers in the U.S. with questions about this recall should contact: 

Additional FDA Resources:

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.