Baxter SIGMA Spectrum Infusion Pump false upstream occlusion alarm correction
Baxter is correcting false upstream occlusion alarms in SIGMA Spectrum and Spectrum IQ infusion pumps following software upgrades affecting approximately 3,306 units distributed nationwide in the US.
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 medical device recall, which requires a minimum severity of 4 per agency classification guidelines. Although no deaths or reported illnesses are documented in the source, false upstream occlusion alarms in infusion pumps could affect clinical decision-making and result in unnecessary interventions.
Plain-English summary
Baxter Healthcare Corporation has issued a correction for the SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps. The correction applies to approximately 3,306 units distributed nationwide in the United States.
The correction addresses an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01. False occlusion alarms could affect clinical decision-making and may result in unnecessary clinical interventions.
Healthcare facilities and end users who operate SIGMA Spectrum or Spectrum IQ infusion pumps with the affected software versions should be aware of this issue. Affected devices can be identified by Product Code 35700BAX2 and GTIN 00085412498683.
Patients and healthcare providers with questions about their infusion pump should contact Baxter Healthcare Corporation or consult the device documentation for guidance on this correction.
The recalled product
- Product
- SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 3,306
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 (3)
- GTIN 00085412498683
- Software version v8.01.01
- Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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