FDA Class I Recall: Dose IQ software used with Spectrum IQ Infusion Pumps by Baxter Healthcare

Aug. 13, 2021

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.

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.

On July 7, 2021, Baxter Healthcare issued an Urgent Medical Device Correction letter to all customers with 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.

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.

FDA recall