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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 61
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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