TOPIC: Abacus Order Entry and Calculation Software by Baxter Healthcare Corporation: Class I Recall - Due to Risk of Medication Label Errors
AUDIENCE: Pharmacy, Risk Manager, Health Professional, Patient
ISSUE: Baxter Healthcare Corporation is recalling the Abacus software application due to a risk that final printed bag labels for compounded mixtures may contain incorrect information. The issue may occur if a user unintentionally or incorrectly modifies a label template that is used to provide clinical care.
Incorrect values or patient names on final printed bag labels for compounded medications may cause serious harm, especially if the wrong amounts or wrong medications are administered to high-risk patients.
There have been 5 complaints, no injuries, and no deaths associated with this software issue.
For more information about this recall, click on the button "Read Recall" below.
BACKGROUND: Abacus is a software application that performs calculations for compounding liquid doses of medications.
RECOMMENDATIONS:
On June 22, 2022, Baxter Healthcare Corporation issued an Urgent Medical Device Correction letter to customers informing them that the company will perform a software upgrade to remove the ability of all Abacus users to change label templates.
- Follow instructions in the Abacus User Guide and Abacus Configuration Guide when creating an order.
- Have a pharmacist review all order outputs, including the printed bag label.
- Ensure facility processes include pharmacy checks during the compounding process as well as a nursing check.
- Do not make updates to bag label templates.
- Contact the company if changes to label templates are needed.
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