Spectrum IQ Infusion Pump Safety Software Recalled for Drug Identifier Mismatch
Baxter is recalling Dose IQ Safety Software for Spectrum IQ Infusion Pumps due to a software defect that creates a mismatch between displayed drug names and the device's drug library. This could lead to incorrect medication administration.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of medical device software that controls drug administration. Per the rubric, FDA Class I recalls cannot score below 4. While no serious injuries or deaths have been reported, the defect creates a clear risk of incorrect medication administration through an infusion pump.
Plain-English summary
Baxter Healthcare Corporation is recalling Dose IQ Safety Software used with Spectrum IQ Infusion Pumps due to a software defect that creates a risk of incorrect medication administration. The software version 9.0.x is affected, with approximately 61 units distributed nationwide in the United States.
The defect creates a mismatch between the drug identifiers displayed in the Dose IQ user interface and the binary drug library loaded onto the Spectrum IQ pump. This inconsistency could cause users to select or administer the wrong medication.
This is an FDA Class I recall of medical device software, the most serious classification level. Healthcare facilities and providers using these systems should seek guidance from Baxter Healthcare Corporation or the FDA regarding the status of their equipment and any required corrective actions.
The recalled product
- Product
- Dose IQ Safety Software used with Spectrum IQ Infusion Pump
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- software-defect
- drug-identifier-mismatch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software version: All libraries initially created with version 9.0.x
Distribution
Distributed nationwide across the United States.
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