BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL STAGE VENOUS CANNULA

    MDR report key: 4182973 · Received October 17, 2014

    Report

    Report Number
    3008500478-2014-00126
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K120072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: VISUAL AND FUNCTIONAL TESTING OF THE RETURNED DEVICE, CONFIRMED THE REPORTED EVENT. A SPLIT WAS OBSERVED THAT PENETRATED THE WALL OF THE CANNULA. WATER WAS FLUSHED THROUGH THE CANNULA AND WAS FOUND TO LEAK THROUGH THE SPIT IN THE CANNULA. PER ENGINEERING EVALUATION, A MANUFACTURING DEFECT COULD NOT BE CONFIRMED. ROOT COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. THE COMPLAINT TREND WAS FOUND TO BE IN CONTROL. RESULT =FRACTURE MATERIAL. ADDITIONAL MANUFACTURER NARRATIVE: DEVICE HISTORY RECORD WAS REVIEWED, NO NON-CONFORMANCES WERE IDENTIFIED RELATED TO THE REPORTED EVENT AND BATCH MET SPECIFICATION PRIOR TO RELEASE. NO MANUFACTURING DEFECT, DESIGN INADEQUACY, OR LABELING/IFU INADEQUACY COULD BE DETERMINED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT, WHILE A DUAL STAGE VENOUS CANNULA WAS BEING USED FOR CARDIOPULMONARY BYPASS (CPB), A ¿FISSURE¿ OF THE CANNULA WAS NOTED. THROUGH INVESTIGATION, IT WAS LEARNED THE SURGEON IDENTIFIED THE CANNULA LEAK. THE CANNULA WAS NOT EXCHANGED BECAUSE THE EVENT OCCURRED AT THE END OF THE CPB RUN. NO ADVERSE PATIENT EVENTS WERE REPORTED. NO VISIBLE INCONSISTENCIES OF THE CANNULA WERE NOTED DURING DEVICE PREPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661471 DUAL STAGE VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES TF3646OA 59705355

    Patients

    Seq Age Sex Outcome Treatment
    1