On August 12, 2021, the U.S Food and Drug Administration (FDA) reported Baxter Healthcare’s recall of the Dose IQ Safety Software used with the Spectrum IQ Infusion System because a software defect may lead to mismatched drug information in drug libraries that were created using version 9.0.x of the computer-based software. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.
The recall affects 61 devices of the Dose IQ Safety Software used with the Spectrum IQ Infusion System with software version 9.0.x and product code 35723V091. The software was distributed from February 1, 2018–January 1, 2019. Baxter Healthcare initiated the recall on July 7, 2021.
A software defect may lead to mismatched drug information in drug libraries created using version 9.0.x of the computer-based software. If the software’s drug identifier does not match the drug information in the pump, the drugs may be improperly configured and cause serious adverse events, including delays in infusion, underinfusion, or overinfusion. Baxter Healthcare received 15 reports of the defect, none of which were associated with injury or deaths.
On July 7, 2021, Baxter Healthcare issued an urgent medical device correction letter to all customers and provided the following instructions for healthcare providers:
- Program the pump in basic mode if a desired drug concentration and delivery mode is not found during pump programming.
- Notify the pharmacy department if a drug configuration is missing on the pump. Pharmacy departments should contact Baxter Technical Assistance if a missing drug configuration in the infusion pump is found in the Dose IQ computer software and the drug library was created with version 9.0.x.
- If you continue to use Dose IQ 9.0.x, maintain heightened awareness. Exercise caution while using Dose IQ 9.0.x if an alternative is not available.
- Customers should complete the customer reply form included with the urgent medical device correction letter and return it by email to email@example.com.
Baxter Healthcare is working on a standalone validated software tool to identify linked drug entries that are affected by the issue. A Baxter representative will contact facilities to make a correction plan when the tool is available, and affected customers will be upgraded to Dose IQ version 9.1.1 or higher.
Customers with questions about the recall should contact Baxter’s Technical Assistance at 800-356-3454 and select prompt 1.
Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using these devices to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.