BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX

    MDR report key: 3242250 · Received July 8, 2013

    Report

    Report Number
    3242250
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 3, 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

    UPON ARRIVAL TO THE PEDS INPATIENT UNIT, THE INSTRUMENT WAS PRIMED AND CONNECTED TO THE PATIENT. VSS. (NO ALARMS WERE NOTED DURING PRIME.) AT 210 WHOLE BLOOD (WB) ALARM #18, SYSTEM PRESSURE WAS NOTED. AFTER FOLLOWING INSTRUCTIONS ON THE INSTRUMENT, THE TREATMENT BEGAN DRAWING AGAIN. AT APPROX 510 ML WB, ALARM #46 ACCELEROMETER SYSTEM ALARM WAS NOTED. I MUTED THE INSTRUMENT, AND CHECKED ALL CONNECTIONS. I CONTACTED THERAKOS FOR FURTHER INSTRUCTION. DUE TO THE LBW OF THE PATIENT, WE DECIDED BEST TO TREAT THE CELLS WE HAD COLLECTED. AFTER REPURGING THE INSTRUMENT AGAIN, A SECOND ALARM WAS NOTED, AGAIN ALARM #46, ACCELEROMETER SYSTEM ALARM AT 635 ML WB. THE TREATMENT WAS THEN ENDED; THE BLOOD IN THE KIT AND CENTRIFUGE BOWL WAS RETURNED TO THE PATIENT, NO BLOOD WAS LOST.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
    312038 CELLEX SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL, KIT LNR THERAKOS,INC. 40156 B310

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR