The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Dose IQ Safety Software (used with Spectrum IQ Infusion System)
- Product Code: 35723V091
- Software Version: All drug libraries initially created with version 9.0.x
- Distribution Dates: February 1, 2018 to January 1, 2019
- Devices Recalled in the U.S.: 61
- Date Initiated by Firm: July 7, 2021
The Dose IQ Safety Software is a standalone computer-based software program that allows care providers to create a drug library of pre-programmed dosing information for specific medications. Those medications are delivered into a person’s body in controlled amounts using the Spectrum IQ infusion pump.
Reason for Recall
Baxter Healthcare is recalling the Dose IQ Safety Software used with the Spectrum IQ Infusion System. 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 delay in therapy, under-infusion, or over-infusion of medication.
There have been 15 complaints, no injuries, and no deaths reported for this issue.
Who May be Affected
- Health care providers using Spectrum IQ Infusion System pumps with Dose IQ software version 9.0.x
- Patients who require care using Spectrum IQ Infusion System pumps with Dose IQ software version 9.0.x
What to Do
On July 7, 2021, Baxter Healthcare issued an Urgent Medical Device Correction letter to all customers with the following instructions for health care 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.
- Customers may not be aware of the drug mismatch issues. Therefore, heightened awareness is needed for providers who continue to use Dose IQ 9.0.x. Caution should be exercised 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 e-mail to firstname.lastname@example.org.
Be aware that Baxter Healthcare is currently working on a standalone validated software tool to identify linked drug entries that are affected by this issue. A Baxter representative will contact facilities to make a correction plan when the tool is available. Affected customers also will be upgraded to Dose IQ version 9.1.1 or higher.
Customers with questions about this recall should contact Baxter’s Technical Assistance at 1-800-356-3454 and select Prompt 1.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.