BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL CANNULA

    MDR report key: 3083465 · Received April 29, 2013

    Report

    Report Number
    3008500478-2013-00424
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K891576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CANNULA WAS VISUALLY INSPECTED AND A CRACK WAS OBSERVED AT THE T-CONNECTOR PORTION OF THE CANNULA. THE DEVICE IS UNDER FURTHER EVALUATION INTO ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CANNULA WAS VISUALLY INSPECTED AND FOUND THE CRACK OBSERVED AT THE T-CONNECTOR PORTION. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MANUFACTURING OPERATORS WILL RECEIVE REFRESHER TRAINING AS INITIAL CORRECTIVE ACTION. FURTHER CORRECTIVE ACTION NEEDS WILL BE ASSESSED THROUGH A PRODUCT RISK ASSESSMENT. THE LABEL AND IFU WERE REVIEWED AND FOUND TO BE ADEQUATE. MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THIS LOT. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD TWO RECENT CASES ON WHICH THE FEM-FLEX FEMORAL ARTERIAL CANNULA HAD LEAKED DUE TO A CRACK IN THE CONNECTOR, NEAR THE BASE OF THE FEMALE LUER FITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183817 FEMORAL CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES DIITFA02225 59388992

    Patients

    Seq Age Sex Outcome Treatment
    1