BD Issues Recall on Alaris Systems Hardware

Cynerio - updated September 3
News
Jul 1, 2020

About the recall

BD issued a recall on a number of Alaris model infusion pumps for hardware defects and malfunctions that can disrupt the devices’ operation on June 30, 2020. The manufacturer issued an addendum to the original recall on August 20.

This recall affects 9 Alaris Infusion Pump models

  • Alaris™ System PC Unit Model 8000
  • Alaris™ System PC Unit Model 8015
  • Alaris™ Pump Module Model 8100
  • Alaris™ Syringe Module Model 8110
  • Alaris™ PCA Module Model 8120
  • Alaris™ EtCO2 Module Model 8300
  • Alaris™ SpO2 Module Model 8210 
  • Alaris™ SpO2 Module Model 8220
  • Alaris™ Auto ID Module Model 8600

The recall on these Alaris devices was issued due to four specific malfunctions, most of which were designated as Class 1 by the FDA:

  1. Damaged Inter-Unit Interface (IUI) connectors
  2. Broken elements on the pump module platen
  3. Improperly secured PC unit batteries
  4. Dim LED segments on the modules

What are Class 1 and 2 FDA recalls?

Class 1 recalls indicate that using the pumps will likely “cause serious adverse health consequences or death.” 

Class 2 recalls indicate that use of the pumps “may cause temporary or medically reversible adverse health consequences” but death and serious damage to patients’ health is unlikely. 

What can be done to fix the issues and how can Cynerio help?

Cynerio will automatically identify every pump in your organization involved in this recall, send you notifications on their locations, and provide mitigation recommendations. 

In addition, hospitals can refer to the original BD recall notices to access specific instructions on how to fix or mitigate each of the hardware malfunctions affecting the devices. 

Some other helpful resources

FDA Safety Alert on BD Alaris System Hardware 

BD Recall Notifications


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