BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA CARDIOWEST

    MDR report key: 3033865 · Received April 3, 2013

    Report

    Report Number
    3033865
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    December 2, 2012
    Report Date
    March 25, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUBJECT (B)(6) HEAR A HISSING SOUND FROM HIS CANNULAE SITE. SILICONE TAPE WAS PLACED UNTIL A COMPLETE CANNULAE REPAIR WAS COMPLETED BY RICH SMITH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137325 SYNCARDIA CARDIOWEST TOTAL ARTIFICIAL HEART (TAH) DSQ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1