This recall involves correcting software for 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 correction.
Affected Product (Include the following information)
- Product Names:
- BD Alaris Systems Manager
- BD Care Coordination Engine (CCE) Infusion Adapter
- Unique Device Identifier (UDI)/Catalog Number:
- BD Alaris Systems Manager: 10885403960123, 10885403519666, 10885403960116/9601
- BD CCE Infusion Adapter: 10885403510472
- Software Versions:
- BD Alaris Systems Manager: Software v12.5.1 or v12.5.2, and prior versions (4.33, 12.0.1, 12.0.2, 12.1, 12.1.2, 12.3)
- BD CCE Infusion Adapter: Software v1.7.2
What to Do
- Review all infusion parameters pre-population to make sure they are correct before starting infusion.
- Work with BD support to remotely update BD CCE Infusion Adapter to v.1.7.3 and remove duplicate Systems Manager software.
On February 18, 2025, Becton Dickinson and Company, and its subsidiary CareFusion, sent all affected customers an Urgent Medical Device Product Correction letter that recommended the following actions:
- Review all pre-populated infusion parameters and confirm they are correct before pressing START, as outlined in the BD Alaris User Manual.
- Share this notice within the facility to make sure all staff are made aware of the issue.
- Complete the customer response form attached to the letter.
- Return to the BD contact noted on the form, whether or not there is any affected product on site.
- BD project managers will engage with facilities to address any questions about the notice and specific next steps for the facility.
- Report any adverse health consequences experienced with the use of this product to BD and FDA's MedWatch Adverse Event Reporting program: www.fda.gov/medwatch, phone: 1-800-FDA-1088 (1-800-332-1088).
- Report complaints with this product to BD through the North American Regional Complaint Center: 1-844-8BD-LIFE (1-844-823-5433).
Reason for Correction
Becton, Dickinson and Company is correcting software for the BD Alaris Systems Manager and BD Care Coordination Engine (CCE) Infusion Adapter after receiving reports that customers running with Systems Manager software who are also connected to the system’s CCE Infusion Adapter may experience delayed system response and backlogging of automated programming requests (APRs). After the delay, outdated APRs may upload to the Alaris computer, presenting different rate, dose, or volume parameters than the current infusion. If the outdated rate/dose change is accepted by the user, a patient could receive inaccurate therapy including over- or under-infusion.
The use of affected product may cause serious adverse health consequences, including complications caused by sudden pump stop or by receiving too much or too little therapy (over- or under-infusion) and death.
There have been no reported injuries. There have been no reports of death.
Device Use
BD Alaris System is an infusion pump and monitoring system for giving ongoing (continuous) or repeat doses (intermittent) fluids such as medication, red blood cells, or other blood products to adults, children, and infants through the blood vessels (intravenous or intra-arterial), under the skin (subcutaneous), into the space between the spinal nerves (epidural), or in fluid spaces of the body.
BD Alaris Systems Manager software connects to Alaris System computers in support of various system components working together. The CCE Infusion Adapter software allows the BD Alaris System and a hospital’s electronic medical record system to work together and support automated workflows for pump programming.
Contact Information
Customers in the U.S. with questions about this recall should contact BD’s Recall Support Center: 888-562-6018 or SupportCenter@bd.com.
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.
