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Terumo® Advanced Perfusion System 1

Terumo Cardiovascular Systems Corporation · Model 802018 · UDI-DI 00886799000687

DWBDTQ Prescription
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

DateFirmReason
2011-10-21Terumo Cardiovascular Systems CorporationTerumo 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
2011-08-29Terumo Cardiovascular Systems CorporationThe Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume.

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Data 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.