According to a recall notice published on fda.gov, the U.S. Food and Drug Administration has issued a Class I recall of Abacus Order Entry and Calculation Software. This type of recall is the most severe classification as the product may cause injury or death. The company initiated the recall on June 22, 2022, and concerns three versions of software with three configurations. The recall affected 1,114 patients.
Abacus is a software program that executes calculations for compounding liquid doses of pharmaceuticals. The Order Entry and Calculation Software calculates the dose mixes according to a physician’s order. The compounded solution is then given to a patient. Baxter Healthcare Corporation recalled the Abacus software program due to a risk that the compounded mixture bag labels could contain incorrect information. This issue can happen when a user incorrectly or unintentionally alters a label template used to provide medical care.
Should incorrect patient names or values be printed on the final bag label for compounded medication, the patient could suffer serious injury, particularly if the wrong medication or wrong amounts are given to high-risk patients.
So far, five complaints associated with this software issue have been submitted to the company.
Health care staff who have administrative permission and administrators are able to use the Abacus software to modify label templates. Health care providers order and administer medicines using the Abacus software to calculate and prepare medications. Patients who receive prescription drugs prepared with the assistance of the Abacus software could be at risk of under- or over-dosing.
Baxter Healthcare Corporation’s Urgent Medical Device Correction Letter informs medical professionals that the company would perform the necessary software upgrade to remove its label template change capabilities. However, the company recommends that users:
- Observe the Abacus User Guide and Abacus Configuration Guide instructions when creating an order.
- Have a pharmacist check order outputs, including any printed bag labels.
- Make sure that all facility processes include pharmacy and nursing checks during the compounding process.
- Avoid making updates to bag label templates.
- Call Baxter Technical Service when label template changes are needed.
- Send a copy of this information to any department that uses this product.
Customers who received the notice from Baxter should let Baxter know that they received the correction letter by issuing the receipt notice on Baxter’s customer portal found at https://BaxterFieldActionCustomerPortal.onprocess.com/. Baxter will also provide additional information to its customers about the updated software as it becomes available. Medical professionals should report any adverse reactions or quality concerns to the FDA’s MedWatch.
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