BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX

    MDR report key: 3242247 · Received July 8, 2013

    Report

    Report Number
    3242247
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 30, 2013
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    FOLLOWING THE PURGE CYCLE DURING ECP TREATMENT, THERE WAS A SYSTEM PRESSURE #18 AT 207 ML WHOLE BLOOD, WHICH PRECEDED A POP NOISE IN THE CENTRIFUGE CHAMBER. BLOOD WAS NOTED ON THE WINDOW OF THE CHAMBER AND WAS FLOWING TO THE DECK OF THE ECP INSTRUMENT. THE INSTRUMENT WAS STOPPED AND LINES WERE CLAMPED. THERAKOS WAS NOTIFIED. PT IV LINES REMAINED INTACT AND ANOTHER INSTRUMENT WAS PRIMED. PT. VS'S WERE STABLE AND ANOTHER TREATMENT WAS STARTED. PT HAD A SUCCESSFUL TREATMENT ON ANOTHER CELLEX INSTRUMENT.NOTES FROM BIOMED WORK ORDER: CLEANED BLOOD FROM PUMPS, DECK CENTRIFUGE AND CHAMBER, AND BEHIND PANELS AS REQUIRED DOWN TO THE WHEELBASE. WHEN THE UNIT WAS REASSEMBLED AND CHECKED OUT THE COLLECT PRESSURE TRANSDUCER WAS AT THE HIGH LIMIT. REPLACED THE TRANSDUCER AND CALIBRATED THE PUMPS AND LOAD CELLS. ALL SYSTEMS CHECKED GOOD.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
    312037 CELLEX SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL, KIT LNR THERAKOS, INC. * B310/360

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR