Baxter has issued an Urgent Medical Device Correction communication regarding the potential risk of medication error when using the Abacus Order Entry & Calculation software. The Abacus software is commonly used with ExactaMix automated compounding devices (ExactaMix 1200 and ExactaMix 2400).
The current Abacus software functionality allows users with administrative permission to access and modify label templates, and the Abacus Configuration Guide provides instructions and warnings for users to safely modify label templates. However, modifying label templates incorrectly may lead to inaccurate information on the final printed bag label. To date, there have been five potentially related complaints with no reports of patient harm associated with this issue.
This recall is a device correction. Customers can continue to use the Abacus software. Baxter is recommending that customers refrain from making updates to bag label templates and contact Baxter Technical Support if updates to bag label templates are needed. Baxter will be performing a software upgrade to remove the capability for Abacus users to modify label templates and will share more information with customers once the software upgrade is available.
For more information, please read the complete letter here.
February 2023 Update
Baxter has provided correspondence as a follow-up to the Urgent Medical Device Correction (FA-2022-017) issued June 22, 2022 for ABACUS Order Entry and Calculation software. Baxter has completed the necessary upgrade actions for the ABACUS software, addressing the potential risk of medication errors when modifying bag label templates. Read more here.