BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA POWER INJECTABLE PORT

    MDR report key: 2608186 · Received June 5, 2012

    Report

    Report Number
    2032582-2012-00004
    Event Type
    Malfunction
    Date Received
    June 5, 2012
    Report Date
    June 4, 2012
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PFM MEDICAL RECEIVED THE COMPLAINT ON (B)(4) 2012. THE DHR WAS REVIEWED. THE RECORDS FOR LOT 11956 000 WERE COMPLETE AND IN ORDER. THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH LOT 11956 000. THE LABELING WAS REVIEWED. THE IFU SHOWS DETAILED/ADEQUATE INSTRUCTIONS FOR THE MAINTENANCE OF THE PORTS AND AVOIDS A FAILURE IN THE FLUID PATHWAY. THE RETURNED SAMPLE WAS TESTED. A FLUSH AND ASPIRATION TEST WAS CONDUCTED ON THE RETURNED PORT. THERE WAS NO DIFFICULTY TO FLUSH OR ASPIRATE THROUGH THE DEVICE. THERE WAS NO RESISTANCE OR OBSTRUCTION. THE SYSTEM WAS NOT BLOCKED. A FLUSH AND ASPIRATION TEST WAS CONDUCTED ON THE RETURNED CATHETER. THERE WAS NO DIFFICULTY TO FLUSH OR ASPIRATE THROUGH THE CATHETER. THERE WAS NO RESISTANCE OR OBSTRUCTION. THE CATHETER WAS NOT BLOCKED. UNABLE TO CONFIRM THE NATURE OF THE COMPLAINT. COULD NOT DUPLICATE CLIENT'S OBSERVATIONS. DEVICE OPERATED AS INTENDED. INABILITY TO ASPIRATE MAY BE DUE TO A FIBRIN TAIL ON THE TIP OF THE CATHETER OR THE CATHETER TIP MAYBE AGAINST THE VESSEL WALL. UNABLE TO CONFIRM COMPLAINT. CONCLUSION: THE REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMITIES WITH THE LOT OF PORT. THE INABILITY TO ASPIRATE WHEREAS IT IS POSSIBLE TO FLUSH COULD BE EXPLAINED BY THE FORMATION OF A FLAP. THE FLAP IS PROBABLY DUE THE PRESENCE OF THE VESSEL WALL TOO CLOSE TO THE EXTREMITY OF THE CATHETER, WITH THE EXTREMITY OF THE CATHETER ORIENTED TO THE VESSEL WALL. NO CORRECTIVE OR PREVENTIVE ACTION IS OPENED, PFM MEDICAL CPP WILL CONTINUE FOR MONITORING THIS KIND OF INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: "THE PORT WAS PLACED IN THE PT'S CHEST, IT WAS ACCESSED WITH A HUBER NEEDLE ASPIRATION COMMENCED AND NO BLOOD RETURNED. THEY FLUSHED AGAIN, ASPIRATED AGAIN, STILL NO BLOOD RETURNED, THE DEFECTIVE PORT WAS REMOVED AND THEY PLACED A NEW ONE." THE PORT AND A SECOND PIECE OF CATHETER WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCELA POWER INJECTABLE PORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS LJT PFM MEDICAL, INC H965451190 111956 000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention