BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX

    MDR report key: 3242320 · Received July 8, 2013

    Report

    Report Number
    3242320
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 29, 2013
    Manufacturer
    THERAKOS
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE TREATING THE PATIENT USING THE CELLEX INSTRUMENT IN ECP, NUMEROUS OCCLUSIONS WERE NOTED DUE TO AIR COMING FROM THE PT'S CENTRAL LINE. ALARM 35; TREATMENT BAG AIR DETECTED AND ALARM 18; SYSTEM PRESSURE X5. (IN THE PAST, THE PATIENT HAS HAD OCCLUSIONS FROM HER CENTRAL LINE, AND IT WAS RESOLVED BY THE PATIENT LYING ON HER LEFT SIDE TO TAKE PRESSURE OFF THE LINE.) THE FIRST ALARM WAS AT 240 WHOLE BLOOD AND SUBSEQUENT ALARMS AT 1004 WB; 1219 WB; 1446 WB AND 1591 WB. OUR THERAKOS REP WAS HERE IN ECP FOR AN IN-SERVICE EARLIER IN THE DAY, AND HE ASSISTED ME TO GET THRU THE ALARMS. OUTCOME: THE FIRST CELLEX KIT WAS WASTED (LOT B310/755) DUE TO AIR IN THE DRAW LINE (RED LUMEN). ENDED TREATMENT, FLUSHED RED AND BLUE LUMENS PER CPG. RE-PRIMED A NEW KIT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ECP TREATMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310216 CELLEX SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL, KIT LNR THERAKOS * B310/755

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR