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Terumo® Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation · Model 803480 · UDI-DI 00886799000779
10
510(k) clearances
1,832
Adverse events (26 deaths)
2
Recalls
3
Facilities
Description
The occluder module serves as the interface between the occluder head and the system. The occluder system is controlled from the CCM, and can be configured to respond to primary pump events.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-10-21 | Terumo Cardiovascular Systems Corporation | Terumo Cardiovascular Systems is aware on one instance in which an incorrectly labeled printed circuit board for the Sarns Modular Perfusion System 8000 was shipped to a single cu |
| 2011-08-29 | Terumo Cardiovascular Systems Corporation | The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume. |
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