BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL ARTERY CANNULA

    MDR report key: 3061133 · Received April 16, 2013

    Report

    Report Number
    3008500478-2013-00420
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K891576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CUSTOMER REPORT OF "PINHOLE IN THE CANNULA" WAS CONFIRMED. A CUT OR PUNCTURE WAS FOUND FROM THE CANNULA BODY AT THE PROXIMAL TIP. THE CUT APPEARED TO BE PENETRATING THE CANNULA FROM OUTER SURFACE TO INNER WALL. THE DEVICE IS CURRENTLY UNDER REVIEW INTO ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CUSTOMER REPORT OF "PINHOLE ON THE CANNULA" WAS CONFIRMED. A CUT OR PUNCTURE WAS FOUND FROM THE CANNULA BODY AT APPROXIMATELY 9 CM PROXIMAL FROM TIP. THE CUT WAS MEASURED APPROXIMATELY 1/50" IN LENGTH. THE CUT APPEARED TO BE PENETRATING THE CANNULA FROM OUTER SURFACE TO INNER WALL. A MANUFACTURING DEFECT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. AWARENESS TRAINING WAS GIVEN TO THE PRODUCTION LINE. A CAPA IS NOT REQUIRED PER CAPA DECISION TREE AT THIS TIME. THE LABEL/IFU IS ADEQUATE. THE DEVICE LOT NUMBER IS NOT KNOWN, THUS A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. OVER THE PAST 2 YEARS THERE HAS NOT BEEN ANY OTHER COMPLAINTS FOR PIN HOLE LEAK FOR THIS DEVICE. THE COMPLAINT TREND REMAINS IN CONTROL, AND TWO YEARS IS AN ADEQUATE TIME PERIOD TO ASSESS COMPLAINT TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "BLOOD LEAKAGE WAS OBSERVED FROM THE PIN HOLE ON THE (FEMORAL ARTERY) CANNULA DURING USE. THE CANNULA WAS INSERTED TO THE ARTERY AND HEART-LUNG MACHINE WAS STARTED. INSERTION DEPTH OF THE CANNULA WAS ABOUT 2CM. AFTER 10 TO 15 MIN, THE CUSTOMER NOTICED A BLOOD LEAKAGE AND A PIN HOLE WAS NOTED AT ABOUT 10CM FROM THE TIP OF THE CANNULA. A DRAPE WAS WRAPPED AROUND THE PIN HOLE AREA AND THE HEART-LUNG MACHINE WAS CONTINUED. HEART-LUNG MACHINE WAS WEANED OFF FROM THE PATIENT AFTER 116MIN OF USE." THE AMOUNT OF BLOOD LOSS COULD NOT BE DETERMINED, BUT TREATMENT ON THE PATIENT FOR THE BLOOD LOSS WAS NOT NECESSARY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162348 FEMORAL ARTERY CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES FEMII018A

    Patients

    Seq Age Sex Outcome Treatment
    1