BD is correcting software for its Alaris Systems Manager and CCE Infusion Adapter after identifying a risk that outdated infusion parameters could be uploaded, potentially leading to incorrect dosing.

Becton, Dickinson and Company is correcting infusion pump 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After the delay, outdated APRs may upload to the Alaris computer, presenting different rate, dose, or volume parameters than the current infusion. If the outdated rate/dose change is accepted by the user, a patient could receive inaccurate therapy including over- or under-infusion.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 and death. There have been no reported injuries, and there have been no reports of death, according to a medical device recall notice from the US Food and Drug Administration.

Affected Products

  • 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  

Device Use

BD Alaris System is an infusion pump and monitoring system for giving ongoing or repeat doses of fluids such as medication, red blood cells, or other blood products to adults, children, and infants through the blood vessels, under the skin, into the space between the spinal nerves, 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. 

What to Do

On Feb 18, 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).

Customers in the US with questions about this recall should contact BD’s Recall Support Center: 888-562-6018 or [email protected]. 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. 

FDA Issues Early Alert on Baxter Spectrum Infusion Pump Recall