The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning BD Alaris Systems, manufactured by CareFusion 303 Inc. (sponsored by BD). The affected devices are identified as the following:

• BD Alaris System PC Unit Model 8000, software versions 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

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

One report of death has been received worldwide in relation to issue 5 above.

The manufacturer is advising these issues will be corrected in an upcoming software release. Affected users are advised to refer to the Customer Letter provided to prevent these from occurring in the interim.

For details, please refer to the following link:
https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2020-RN-00153-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 21 February 2020