BEUDAMED
    FDA Adverse Event Death Summary report: N

    TERUMO 8000 PERFUSION SYSTEM

    MDR report key: 975344 · Received December 27, 2006

    Report

    Report Number
    1828100-2006-00518
    Event Type
    Death
    Date Received
    December 27, 2006
    Date of Event
    November 24, 2006
    Report Date
    December 27, 2006
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL ANTICIPATED BUT NOT YET BEGUN. THE DEVICE HAS NOT BEEN MADE AVAILABLE TO THE MFR FOR EVAL. NO MALFUNCTION OF THE DEVICE WAS ALLEGED TO HAVE OCCURRED.

    Description of Event or Problem · 1

    DURING A CARDIOPULMONARY BYPASS PROCEDURE, AIR WAS OBSERVED IN THE AORTIC CANNULA. EFFORTS WERE MADE TO REMOVE THE AIR FROM THE PT'S CIRCULATION. AFTER COMPLETION OF SURGERY, THE PT REGAINED NO NEURO FUNCTION AND EXPIRED THE NEXT DAY. THE SUBJECT DEVICE WAS NOT ASSERTED TO HAVE BEEN THE CAUSE OF THE AIR IN THE EXTRACORPOREAL CIRCUIT, NOR WAS ANY MALFUNCTION OF THE DEVICE ASSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO 8000 PERFUSION SYSTEM HEART LUNG CONSOLE DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16395 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *