BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX

    MDR report key: 3242252 · Received July 8, 2013

    Report

    Report Number
    3242252
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 5, 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

    PEDIATRIC PATIENT SCHEDULED FOR ECP TODAY AT 8 AM; TREATMENT WAS NOT COMPLETED, DID NOT RECEIVED TREATED WBCS AS INTENDED:ECP CELLEX INSTRUMENT WAS PRIMED WITH ACDA BY COLLEAGUE WHO REPORTED ONE "#23 RETURN TEST PRESSURE FAILURE" ALARM AFTER POWERING UP INSTRUMENT TO BEGIN PRIMING PROCESS; ALARM CLEARED AND DID NOT RECUR.ECP TREATMENT WAS BEGUN FOR THIS INPATIENT IN USUAL MANNER PER ECP LOW WEIGHT SPG. EARLY IN TREATMENT HAD TOTAL OF THREE "#9 BLOOD PUMP ERROR" ALARMS, ABOUT 20ML (WHOLE BLOOD PROCESSED) APART, LAST AT 157ML WBP. PRIOR TO EACH ALARM NOTED THERE WAS A BRIEF, RAPID CLICKING NOISE FROM THE COLLECTION PUMP AND THEN PUMP APPEARED TO GET STUCK AND NOT BE ABLE TO TURN. PUMP WAS EXAMINED AND NO VISIBLE OBSTRUCTION WAS NOTED, ABLE TO TURN PUMP HANDLE FREELY.CONSULTED THERAKOS TECH SUPPORT RE: ABOVE ALARMS. RECOMMENDATION WAS TO END TREATMENT AND RETURN BLOOD PRODUCTS TO PATIENT WITHOUT TREATING ANY WBCS AS THIS ALARM WAS LIKELY TO RECUR AND PREVENT COMPLETION OF TREATMENT; THIS WAS DONE. POSSIBILITY OF KIT DEFECT AND/OR TRANSDUCER OUT OF CALIBRATION ON CELLEX INSTRUMENT.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
    310038 CELLEX SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL, KIT LNR THERAKOS, INC. N/A B310/96

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR