FDA Device Intelligence
Home › Terumo Cardiovascular Systems Corporation › Terumo® Advanced Perfusion System 1

Terumo® Advanced Perfusion System 1

Terumo Cardiovascular Systems Corporation · Model 802112 · UDI-DI 00886799000724

DWBDTQ Prescription
10
510(k) clearances
1,832
Adverse events (26 deaths)
2
Recalls
3
Facilities

Description

The pressure module serves as the interface between up to two pressure transducers and the system. This module monitors signals from the pressure transducers and communicates pressure values, alerts, and alarms to the system.

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.