BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX

    MDR report key: 3959407 · Received July 17, 2014

    Report

    Report Number
    3959407
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    April 10, 2014
    Report Date
    July 15, 2014
    Manufacturer
    THERAKOS
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A LOUD, EXPLOSIVE NOISE WAS HEARD FROM THE CELLEX CENTRIFUGE CHAMBER AT 1417ML WHOLE BLOOD PROCESSED. IMMEDIATELY TURNED THE INSTRUMENT OFF. PATIENT APPEARED STABLE AND NO COMPLAINTS OFFERED. VITAL SIGNS STABLE. PHYSICIAN CONTACTED AND THERAKOS NOTIFIED.PHYSICIAN CONSULTED AND AGREED THAT PATIENT COULD RECEIVE ECP TREATMENT ON ANOTHER INSTRUMENT. PATIENT RECEIVED A SUCCESSFUL ECP TREATMENT ON ANOTHER CELLEX INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418814 CELLEX SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL, KIT LNR THERAKOS * C 302

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR NOT APPLICABLE.