BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR SHUNT

    MDR report key: 2962374 · Received February 14, 2013

    Report

    Report Number
    3008500478-2013-00391
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 25, 2013
    Report Date
    March 27, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K860497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CUSTOMER REPORTED THE BALLOON WAS NOT HOLD THE PRESSURE WAS NOT CONFIRMED. THE BALLOON WAS INFLATED PROPERLY AND REMAINED INFLATION WITHOUT ANY DEFECTS. THE SHUNT LEAK TEST WAS PERFORMED AND PASSED. THE DEFECT COULD NOT BE CONFIRMED THUS A ROOT CAUSE CAN NOT BE DETERMINED. NO CORRECTIVE ACTION REQUIRED. A MANUFACTURING DEFECT WAS NOT CONFIRMED, AND THE COMPLAINT TREND REMAINS IN CONTROL. MANUFACTURING RECORDS HAVE BEEN REVIEWED AND THERE ARE NO NONCONFORMANCES. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE IS CURRENTLY UNDER INVESTIGATION INTO ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT "DURING USE, THE BALLOON SEPARATED AND WOULD NOT PUMP ON THE VASCULAR SHUNT . PATIENT EXPERIENCED BLEEDING DURING THE PROCEDURE." THE HOSPITAL DID NOT KNOW HOW MUCH BLOOD WAS LOST BUT ACCORDING TO THE DESCRIPTION THAT WAS WRITTEN IT STATES THAT THE ITEM WAS PREPARED AS USUAL. BROUGHT SHUNT UP TO PLACE IN PATIENT. INFLATED BALLOON AND IT KEPT SEPARATING JUST ABOVE THE LL JUNCTION AND WOULD NOT HOLD BALLOON PRESSURE. HAD TO RE-CLAMP WHICH CAUSED UNDO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65662 VASCULAR SHUNT CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES T3103AS 59229537

    Patients

    Seq Age Sex Outcome Treatment
    1 Other