Device product
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
Z-1389-2020
Product summary
- Event
- Event 84732
- Status
- Terminated
- Classification
- Class III
- Quantity
- 27 packs
- Official record key
device-enforcement:Z-1389-2020
Official wording
Reason: Perfusion tubing pack was packaged with the incorrect cuvette.
Code information: Model Number: 046008200 Lot Number: 1912100141 UDI: (01)00803622140136(240)046008200 (17)210430(10)1912100141 Cuvette Component P/N 03016 - SAT/HCT B-care 5 cuvette
Distribution pattern: US Nationwide distribution in the state of IL.
Derived failure modes
-
Unknown
Perfusion tubing pack was packaged with the incorrect cuvette.