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Terumo® Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation · Model 802113 · UDI-DI 00886799000731
1
510(k) clearances
1,832
Adverse events (26 deaths)
2
Recalls
3
Facilities
Description
The RS-232 Interface Module provides the interface between the RS-232 protocol data acquistion software and the system. The module outputs system data to the data acquisition software such as Tlink Data management Software.
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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