Baxter SIGMA Spectrum Infusion Pump Software Recall for Dose Display Discrepancy
Baxter is recalling SIGMA Spectrum Infusion Pump software due to a discrepancy between Master Drug Library settings and pump display, which may cause therapy delays or unintended delivery rates.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a software discrepancy may cause unintended rates of drug delivery or therapy delays. Per the rubric, this is classified as High (Score 3) because it is a risk-of-harm product where specific injury or illness has not yet been reported in the source text.
Plain-English summary
Baxter Healthcare Corp is recalling Master Drug Library Software version 8.0 (Product Code 35723V080) used with the SIGMA Spectrum Infusion System (Pump) version 8.0 (Product Code 35700BAX2). The recall involves 58 units of the Master Drug Library software.
The recall is issued because loading and bolus default dose settings in the Master Drug Library may differ from the values shown on the pump during programming. Specifically, drug dose times in seconds are rounded to the nearest integer in minutes on the pump dose setup screen; for example, a setting of 20 seconds may display as 1 minute. Although the pump administers drugs as configured, this discrepancy may cause therapy delays or unintended rates of delivery.
The affected software was distributed worldwide, including in the United States (specifically to CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, SD, TX, UT, WV, and Puerto Rico) and Canada. Healthcare facilities should contact Baxter Healthcare Corp for further instructions on how to address the software discrepancy.
The recalled product
- Product
- Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled…
- Manufacturer
- Baxter Healthcare Corp
- Affected units
- 58
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 (2)
- Software version 8.0
- Product Code 35723V080
Distribution
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