BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2063295 · Received April 19, 2011

    Report

    Report Number
    2015691-2011-15258
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    KRA
    PMA / PMN Number
    K924661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SWAN-GANZ CATHETER WAS RECEIVED WITH THE MONOJECT LIMITED VOLUME SYRINGE FOR EVALUATION. THE REPORTED NONCONFORMANCE OF "WHEN FLUSHING THE DISTAL HUB, THE FLUID EXITED THE PROXIMAL PORT" WAS CONFIRMED. A GENERAL VISUAL EXAMINATION WAS PERFORMED AND THE CATHETER BODY, BALLOON AND WINDINGS ARE ALL IN GOOD CONDITION. A 10CC SYRINGE WAS CONNECTED TO EACH OF THE LUMENS BEING TESTED. EACH ASSOCIATED PORT WAS COVERED WITH A FINGER TIP; ENTIRE CATHETER WAS IMMERSED IN WATER AND PRESSURIZED WITH AIR BY COMPRESSING THE SYRINGE PLUNGER. ANY LEAKAGE (BUBBLES EXITING) FROM THE CATHETER BODY OR FROM ANY CONNECTOR WAS VISUALLY EXAMINED. ALL THROUGH LUMENS WERE PATENT. NOTED DURING THE LEAK TEST WAS THAT WHEN PRESSURIZING THE DISTAL LUMEN THE PROXIMAL INJECTATE PORT HAD TO BE PLUGGED AND WHEN PRESSURIZING THE PROXIMAL INJECTATE LUMEN THE DISTAL PORT HAD TO BE PLUGGED. THE CATHETER WAS COMPARED TO THE APPLICABLE DRAWING AND THE DISTAL AND PROXIMAL INJECTATE EXTENSION TUBES WERE FOUND TO BE OUT OF POSITION. A RISK ASSESSMENT WAS PREVIOUSLY CONDUCTED FOR THIS ISSUE; THE OPERATORS WERE MADE AWARE OF THIS COMPLAINT AND WERE RETRAINED TO THE MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET SPECIFICATION UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN FLUSHING A SWAN PRIOR TO USE, IT WAS NOTED THAT WHEN FLUSHING THE DISTAL HUB, THE FLUID EXITED THE PROXIMAL PORT; IT WAS BELIEVED THAT THE LINES ARE TRANSPOSED INSIDE THE SHAFT. THE PRODUCT LOOKS NORMAL OUTSIDE. THE TRASH WAS TAKEN OUT PRIOR TO DISCOVERING THIS SO THE PACKAGING IS NOT AVAILABLE. THE LOT NUMBER THAT WAS ON THE SHELF AT THE TIME WAS LOT # 58943412. THERE WERE NO PATIENT COMPLICATIONS; THE DEVICE WAS NEVER USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCO/VIPTHERMODILUTION CATHETER WITH AMC THROMBOSHIELD CONTINOUS CARDIAC OUPTUT CATHETER KRA EDWARDS LIFESCIENCES, PR 139HF75P 58943412

    Patients

    Seq Age Sex Outcome Treatment
    1