Dive Brief:
- Baxter Healthcare is recalling its Abacus Order Entry and Calculation software, which is used for compounding liquid medications. Baxter is recalling three versions of the software, affecting a total of 1,114 customers.
- The company is recalling the software because of mistakes on the final printed medicine labels. The Food and Drug Administration said in a Monday recall notice that incorrect information on final labels for compounded medication, such as incorrect values or patient names, can cause serious harm if the error is not caught.
- Baxter reported five complaints and no injuries. The company said in a statement issued Friday that it is developing a software upgrade that would no longer allow users to modify the label templates.
Dive Insight:
Baxter is recalling the Abacus software application because of the risk that final printed bag labels for compounded liquid medicines may contain “incorrect information,” the FDA said in a statement issued late Monday. The regulator said the problems could occur if a user “unintentionally or incorrectly modifies a label template.”
The FDA classified the recall as Class I, meaning the problem could cause serious injuries or death. The agency said there have been five complaints, no injuries and no deaths associated with the software issue.
Abacus is an application that performs calculations for compounding liquid doses of medications. When connected to a compounder that mixes these doses according to the calculation, the Abacus software can translate a physician’s order into a compounded solution ready to be given to a patient, the FDA said.
Inaccuracies can include the wrong infusion rate or an incorrect patient name if the label is incorrectly modified, according to Baxter.
“Having inaccurate information on the final printed bag labels of compounded medications can cause serious harm, especially in high-risk patients,” that could lead to a patient having electrolyte abnormalities, glucose issues and/or fluid-related complications, the company added.
Required pharmacist and nursing checks can “help mitigate the risk of harm” from an incorrect label, the company said.
Baxter recommended that customers who use the Abacus Order Entry and Calculation Software stop making updates to bag label templates, and have a pharmacist thoroughly review all order outputs, including the printed bag label, for accuracy and safety.
The Abacus software is commonly used with ExactaMix automated compounding devices ExactaMix 1200 and ExactaMix 2400, the company said.
Shares in Baxter remained virtually unchanged from Monday’s close of $66.26 in early trading on Tuesday.
