This week, the US Food and Drug Administration (FDA) characterized Baxter Healthcare’s pharma compounding software recall as a Class I recall, indicating that the Abacus device could result in serious injury or death. This type of recall is considered the most serious safety rating issued by the FDA. Baxter sent an Urgent Medical Device Correction letter on a June 22, 2022, informing users that a planned software upgrade will correct the issue. They have also initiated the recall process.
Abacus Compounding Software for Order Entry and Calculation
The Abacus device assists physicians in prescribing and dispensing medications to patients. The software performs calculations to guide compounding liquid medications. It is connected to a compounder that mixes and dispenses the medication into solutions based on the software’s calculations.
Five complaints have been issued due to misfunction of the software, which led to incorrect information listed on the medication bag labels. This error can occur if the software user mistakenly modifies the label template. Incorrect doses or patient names on the final labels can cause patients to receive the wrong medication. Despite the filed complaints, there have been no injuries or deaths reported to date.
Details on the Abacus Recall
The software recall affects nine devices distributed between May 20, 2013, and September 20, 2019. Baxter has recommended that Abacus users follow instructions outlined in the user and configuration guides for the product prior to processing orders. They also suggest having a pharmacist review orders and that both pharmacy and nurse checks be conducted on every order. Baxter also recommends that no changes be made to label templates that would affect information on the bags.
Highlighting the Risks of Healthcare Technology
Baxter’s recall reflects the growing recognition of safety issues when using technology to assist in healthcare processes. Many new software programs, including electronic health records programs, have put both healthcare professionals and patients at risk due to malfunctioning software. While healthcare technology aims to reduce workload and streamline processes to accelerate patient care, these devices can cause serious harm due to user error or malfunction.