BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2182820 · Received July 8, 2011

    Report

    Report Number
    1828100-2011-01927
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 8, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE CABLE PULLED OUT OF THE OCCLUDER HEAD AT STRAIN RELIEF AND THE WIRES WERE FRAYED. THE OCCLUDER HEAD WORKED WHEN THE CABLE WAS KINKED IN ONE DIRECTION AND DIDN'T IN ANOTHER DIRECTION. HEMOSTATS WERE USED INSTEAD OF THE OCCLUDER FOR THE SURGERY. THE USER REPORTED, THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 OCCLUDER HEAD DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 806455

    Patients

    Seq Age Sex Outcome Treatment
    1