BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, CELL EX, PHOTOPHERESIS, PROCEDURAL

    MDR report key: 2193020 · Received August 1, 2011

    Report

    Report Number
    2193020
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 1, 2011
    Manufacturer
    THERAKOS
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STARTED EXTRACORPOREAL PHOTOPHORESIS (ECP) AND IT WAS NOTED TO HAVE THREE RETURN PRESSURE ALARMS. TREATMENT WAS PAUSED AND THE BLUE LUMEN WAS NOTED TO HAVE OCCLUDED AND WAS UNABLE TO BE USED. THE WHITE LUMEN ALSO OCCLUDED SO THE MACHINE WAS CHANGED TO A SINGLE LUMEN TREATMENT VIA THE TRIFLOW CATHETER. AFTER 155ML BLOOD WAS PROCESSED, A "POPPING NOISE" WAS HEARD. THE NURSE THEN NOTED THAT THERE WAS BLOOD LEAKING FROM THE PRESSURE TRANSDUCER AND THERE WAS LEAKING UNDER THE PUMP TUBING ORGANIZER. THE TREATMENT WAS IMMEDIATELY STOPPED. THE LINES WERE CLAMPED AND THE RED PORT OF THE TRIFLOW WAS FLUSHED WITH 10ML OF NORMAL SALINE AND 3ML OF HEPARIN WITH A CONCENTRATION OF 10UNITS PER ML AND CLAMPED. THERE WERE THREE PT ALERTS. THE PT'S ON A VENTILATOR WITH OXYGEN SATURATIONS OF 98%. THE PHYSICIAN WAS MADE AWARE AND INFORMED OF THE 155ML BLOOD LOSS. THE PT WAS ASYMPTOMATIC AND THE PHYSICIAN OKAYED TO RETREAT WITH THE ECP. DUE TO PT SCHEDULING, HIS TREATMENT WAS CHANGED TO THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, CELL EX, PHOTOPHERESIS, PROCEDURAL CELL EX KIT; PHOTOPHERESIS PROCEDURAL KIT LNR THERAKOS CLXUSA Z307/ 2

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR