Device product
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
Z-2030-2012
Product summary
- Firm
- Sigma
- Event
- Event 61691
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,048 CD's
- Official record key
device-enforcement:Z-2030-2012
Official wording
Reason: Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices.
Code information: All versions
Distribution pattern: Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.
Derived failure modes
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Device software or design
software associated with the SIGMA Spectrum Infusion Pump System because it may result in