BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 9000

    MDR report key: 1880119 · Received October 13, 2010

    Report

    Report Number
    1828100-2010-01894
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    August 19, 2010
    Report Date
    October 13, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K871131
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT CONCLUDED.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE, THE SERVICE TECHNICIAN REPORTED THE END CAP ASSEMBLY OF THE OCCLUDER WAS BROKEN OFF. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 9000 OCCLUDER DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 164560

    Patients

    Seq Age Sex Outcome Treatment
    1