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Terumo® Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation · Model 802018 · UDI-DI 00886799000687
10
510(k) clearances
1,832
Adverse events (26 deaths)
2
Recalls
3
Facilities
Description
The flowmeter module provides the interface between the flow sensor and the system. The module processes the signals necessary to compute fluid flow values. Those flow values are then communicated to the system. Flowmeter values are displayed on the CCM and, if assigned, on a pump's local display.
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
