Device product
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Z-2165-2021
Product summary
- Event
- Event 88246
- Status
- Terminated
- Classification
- Class I
- Quantity
- 61 units
- Official record key
device-enforcement:Z-2165-2021
Official wording
Reason: Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.
Code information: Software version: All libraries initially created with version 9.0.x
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Device software or design
Software issue: The defect