Baxter recalls Abacus pharma compounding software over risk of labeling errors

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Dive Short:

  • Baxter Health care is recalling its Abacus Purchase Entry and Calculation program, which is used for compounding liquid remedies. Baxter is recalling three versions of the software package, impacting a total of 1,114 clients.  
  • The firm is recalling the application mainly because of blunders on the remaining printed medication labels. The Food and Drug Administration said in a Monday remember discover that incorrect information on ultimate labels for compounded treatment, this kind of as incorrect values or individual names, can cause significant damage if the mistake is not caught.
  • Baxter described 5 issues and no accidents. The business stated in a statement issued Friday that it is producing a software program up grade that would no for a longer period permit buyers to modify the label templates. 

Dive Perception:

Baxter is recalling the Abacus computer software software because of the hazard that ultimate printed bag labels for compounded liquid medications could comprise “incorrect info,” the Food and drug administration explained in a assertion issued late Monday. The regulator explained the difficulties could arise if a user “unintentionally or incorrectly modifies a label template.”

The Food and drug administration categorized the recall as Class I, indicating the challenge could result in really serious injuries or demise. The company said there have been five complaints, no accidents and no deaths linked with the software package challenge.

Abacus is an software that performs calculations for compounding liquid doses of remedies. When connected to a compounder that mixes these doses according to the calculation, the Abacus computer software can translate a physician’s order into a compounded answer completely ready to be specified to a individual, the Food and drug administration stated.

Inaccuracies can involve the mistaken infusion price or an incorrect affected person identify if the label is improperly modified, in accordance to Baxter. 

“Having inaccurate details on the final printed bag labels of compounded medicines can bring about major harm, especially in high-chance patients,” that could lead to a individual acquiring electrolyte abnormalities, glucose concerns and/or fluid-relevant issues, the enterprise additional.

Demanded pharmacist and nursing checks can “help mitigate the risk of harm” from an incorrect label, the business stated.

Baxter encouraged that customers who use the Abacus Get Entry and Calculation Software program halt generating updates to bag label templates, and have a pharmacist totally review all purchase outputs, together with the printed bag label, for accuracy and protection.

The Abacus application is frequently made use of with ExactaMix automated compounding gadgets ExactaMix 1200 and ExactaMix 2400, the company explained.

Shares in Baxter remained just about unchanged from Monday’s close of $66.26 in early buying and selling on Tuesday.

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