Device product
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Z-0094-2024
Product summary
- Event
- Event 93105
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1383
- Official record key
device-enforcement:Z-0094-2024
Official wording
Reason: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Code information: Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109, 15032-000-0027/7290109150147, 15038-000-0001/7290109150161
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Device software or design
software revision may fail to detect air in line, which may