Manufacturer Recalls: BD Alaris Pump Systems

Manufacturer Recalls: BD Alaris Pump Systems

Issue
BD™ recently sent out an Urgent Medical Device Recall Notification regarding BD Alaris Pump Systems. Please ensure that you read this notification immediately and in its entirety to determine what mitigation steps to take until the issues have been re-mediated with an upcoming software release. 

Recalled Products

This notification applies to the following devices: 

  • BD Alaris System PC Unit Model 8000, software version 9.5 and prior
  • BD Alaris System PC Unit Model 8015, software versions 9.33 and prior
  • BD Alaris Pump Module Model 8100, software versions 9.33 and prior
  • Alaris Syringe Module Model 8110, software versions 9.33 and prior
  • Alaris PCA Module Model 8120, software versions 9.33 and prior

This Notification Addresses the Following Issues

Issue 1: Software errors related to System Error Code 255-xxx-xxx

Issue 2: Delay Options programming

Issue 3: Low Battery Alarm Failure

Issue 4: Keep Vein Open (KVO)/ End of Infusion alarms priority

Issue 5: Use Errors related to Custom Concentration programming

BD's Solution

"BD intends to address the issues described in this letter through an upcoming software release. BD will update the software for affected devices at no charge. BD will contact affected customers to initiate the scheduling process for the software update when the software becomes available. Without the software update, your device may remain vulnerable to the potential risks associated with each issue described in this letter."

BD Contact Information:

Contact Contact Information Areas of Support
BD Customer
Advocacy


Phone: 888-812-3266
Phone Hours: 7AM-5PM PT Mon-Fri
Email: customerfeedback@bd.com
Product Complaints
Training
Resources


BD has established a website for easy access to
training resources and to support customers with
this recall.
Please visit www.bd.com/alaris-system-software-recall
End-user training outlined in this
notification
Clinical &
Pharmacy
Support
Center


Phone: 858-617-1316
Phone Hours: 5AM-5PM PT Mon-Fri
Email: GMB-AlarisMedSafetyProgram@bd.com
Clinical or Pharmacy related questions
BD Recall
Support
Center


Phone: 888-562-6018
Phone Hours: 7AM-4PM PT Mon-Fri
Email: SupportCenter@bd.com
Recall Related Questions
Technical
Support
Phone: 888-812-3229
Phone Hours: 6AM-5PM PT Mon-Fri
Email: DL-US-INF-TechSupport@bd.com
Technical Questions


US Med-Equip's Solution

All BD Alaris devices affected in the recall will be removed from rent and pulled off the shelves in order to fix the software problem. Until further notice, we will be vigilantly watching out for any incoming and outgoing units to ensure that they are working properly before putting them back out on rent. If you have an affected BD Alaris device from USME, please email  QA@usmedequip.com to place your report and get your unit replaced.

The US Med-Equip Mission

Our Mission is to promote the healing process by providing smart solutions for our partners and the patients they serve.

We are committed to your patients as much as you are — it’s rooted in our daily actions — so we understand the importance of safely servicing recalls promptly.

For any further questions regarding equipment recalls, please email QA@usmedequip.com