The FDA’s recall is based on five complaints that allege the software poses a risk to patients through printed labels it produces for compounded medication mixtures. They sometimes contain incorrect information if users unintentionally or incorrectly modify label templates. There are multiple fields within the label template that users can modify, and the potential is highly variable depending on which field has been changed incorrectly, according to a statement from Baxter.
Incorrect values or patient names on labels can cause serious harm if patients are receiving the wrong amounts or medications, the FDA says. Wrong medications and doses can cause electrolyte abnormalities and glucose issues.
There are no recorded injuries or deaths associated with the software issue, but more than 1,100 customers were affected between May 2013 and September 2019. The recall applies to nine versions of the Abacus software, some dating as far back as 2013, according to Baxter’s website. The product is designed to streamline liquid medication mixing processes for hospitals.
On June 22, the company sent a letter to customers informing them that it would need to upgrade the software to remove the ability to change label templates. In the meantime, Baxter recommends users stop modifying label templates and have pharmacists review all order outputs given by the Abacus software. It’s unclear where in the process Baxter is in rectifying the issue. Baxter did not immediately respond to a request for comment.
Baxter, which also makes dialysis machines and other equipment for operating rooms and intensive care units, offers its product in more than 100 countries. The company acquired Hillrom, a maker of hospital beds, patient monitors and other medical equipment, last year in a deal that’s allowed Baxter to boost revenues since.