BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK DRAW VENOUS CANNULA

    MDR report key: 3840535 · Received May 30, 2014

    Report

    Report Number
    3008500478-2014-00074
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 12, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K962835
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDER EVALUATION INTO ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    EVALUATION: VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE BARBED CONNECTOR HAD BECOME SEPARATED FROM THE ESTANE HUB OF THE CANNULA. THE COMPLAINT THAT THE BARBED CONNECTION OF THE DEVICE HAD SEPARATED FROM THE CANNULA WAS CONFIRMED. PULL TESTING OF THE CONNECTOR FOUND THAT THE FORCE NECESSARY TO SEPARATE THE CANNULA FROM THE BARBED CONNECTOR WAS GREATER THAN EDWARDS SPECIFICATIONS. A MANUFACTURING DEFECT IS UNABLE TO BE CONFIRMED, HOWEVER THE INSTRUCTION IN THE PROCEDURE HAS BEEN DEEMED INSUFFICIENT. THE PROCEDURE HAS BEEN UPDATED AND OPERATORS WILL BE TRAINED ACCORDINGLY. CORRECTIVE ACTIONS HAVE BEEN INITIATED TO ADDRESS THIS ISSUE. MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO RELATED NON CONFORMANCES FOUND. THE INSTRUCTIONS FOR USE, TRAINING, AND RISK CONTROL MEASURES ARE APPROPRIATE AT THIS TIME. TRENDS WILL CONTINUE TO BE MONITORED ON THROUGH THE EDWARDS QUALITY SYSTEM.

    Description of Event or Problem · 1

    AS REPORTED A QD25, QUICKDRAW VENOUS CANNULA WAS DETACHED WHEN START UP OF HEART LUNG MACHINE. WHEN THE BYPASS STARTED THE ALARM SOUNDED, THE CONNECTION WAS SEPARATED BETWEEN THE CANNULA AND THE CONNECTOR. THE QUANTITY OF BLOOD LOST WAS UNKNOWN, BUT THE PATIENT WAS NOT AFFECTED. THE DEVICE WAS NOT EXCHANGED, THEY FIX IT WITH A PLASTIC RING. AS PER SALES MAYBE DUE TO GLUE. THE DEVICE WAS INSPECTED PRIOR TO USE AND THERE WHERE NO PROBLEMS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319502 QUICK DRAW VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES QD25 59655687

    Patients

    Seq Age Sex Outcome Treatment
    1