Device product
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump
Z-2581-2024
Product summary
- Event
- Event 94988
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17,377 units
- Official record key
device-enforcement:Z-2581-2024
Official wording
Reason: The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
Code information: Pump GTIN 00085412498683; All serial numbers with radio software versions 22D28, 22D29, and 22D30
Distribution pattern: US, Nationwide
Derived failure modes
-
Device software or design
software issue