Device product
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Z-2096-2025
Product summary
- Event
- Event 97072
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 28 units
- Official record key
device-enforcement:Z-2096-2025
Official wording
Reason: Certain Spectrum infusion pumps may have an incorrect version of software.
Code information: UDI-DI: 00085412498683; Serial Numbers: 2006307 , 2052091 , 2093765 , 2095360 , 2104302 , 2119236 , 2141815 , 2025925 , 2067699 , 2094483 , 2095541 , 2105238 , 2119436 , 2143406 , 2034297 , 2074097 , 2094580 , 2096351 , 2105769 , 2135482 , 2143684 , 2051591 , 2090658 , 2095202 , 2096856 , 2118940 , 2137976 , 2156201
Distribution pattern: US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
Derived failure modes
-
Device software or design
incorrect version of software