BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX

    MDR report key: 2903261 · Received December 28, 2012

    Report

    Report Number
    2903261
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 28, 2012
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED ECP TREATMENT ON THE CELLEX MACHINE. X7 RBC PUMP ALARMS DURING TREATMENT. ALARMS AT 610ML, 631ML, 661ML, 745ML , 779ML 813 AND 831ML OF WHOLE BLOOD PROCESSED.AFTER 1ST ALARM, COLLECTION RATE DECREASED FROM 25 TO 20. AFTER 3RD RBC PUMP ALARM; MACHINE PAUSED/STOPPED AND AFTER REPURGING, ALLOWED TO PAUSE X2 MINUTES (PLASMA SLIGHTLY CLOUDY AND RBC STREAMING NOTED IN BOWL).THERAKOS CONTACTED, ADVISED TO GO TO EARLY BUFFY COAT. TOTAL OF 970ML OF WBP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLEX KIT, SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS, INC. * A323/23

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR