Baxter has issued an Urgent Medical Device Correction regarding the potential risk of medication error when using certain product codes for the Abacus Order Entry and Calculation Software.
The Abacus software is commonly used with ExactaMix automated compounding devices (ExactaMix 1200 and ExactaMix 2400). Baxter previously communicated about this issue to customers via an Urgent Medical Device Correction notification on June 22, 2022.
See the affected product codes here.
The 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, such as the wrong infusion rate or incorrect patient name. There are multiple fields within the bag label template that can be modified, and the potential harm is highly variable depending on which field has been modified incorrectly.
Having inaccurate information on the final printed bag labels of compounded medications can cause serious harm, especially in high-risk patients. When incorrect information is printed on the Abacus bag label, there is a possibility it could lead to a patient having electrolyte abnormalities, glucose issues and/or fluid-related complications. There are required pharmacist and nursing checks typical of standard clinical practice that can help mitigate the risk of harm, in the event there is incorrect information printed on the bag label. To date, there have been five related complaints with no reports of patient harm associated with this issue.
Baxter recommends that customers discontinue making updates to bag label templates and contact Baxter Technical Support if updates to bag label templates are needed. Customers should continue to follow the instructions in the Abacus User Guide and Abacus Configuration Guide when creating an order and have a pharmacist thoroughly review all order outputs, including the printed bag label, for accuracy and safety. They should also ensure their facility procedures include pharmacy and nursing checks throughout the parenteral nutrition compounding process.
