BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX KIT

    MDR report key: 3712111 · Received March 20, 2014

    Report

    Report Number
    3712111
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    October 11, 2013
    Report Date
    March 16, 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

    BEGAN ECP VIA RED & BLUE LUMENS OF PATIENT'S NEOSTAR CVC USING CELLEX INSTRUMENT AND CELLEX KIT LOT # B330/396. NOTED FINE "CHAMPAGNE" AIR BUBBLES IN COLLECT LINE BEGINNING AT LUER CONNECTION. SWITCHED COLLECT LINE TO BLUE LUMEN & RETURN LINE TO RED LUMEN WITH NO IMPROVEMENT; SWITCHED LINES BACK TO ORIGINAL CONFIGURATION WITH NO IMPROVEMENT AND HAD #18 SYSTEM PRESSURE ALARM. MUCH AIR NOTED IN COLLECT LINE. CLAMPED COLLECT LINE, SELECTED "END TREATMENT" OPTION & RETURNED BLOOD PRODUCTS BACK TO PATIENT. CONFERRED WITH THERAKOS TECH SUPPORT WHO PROVIDED RGA # AND WILL CREDIT KIT. A NEW KIT WAS PRIMED ON A DIFFERENT CELLEX & ECP PROCEEDED WITHOUT DIFFICULTY. PATIENT ALSO STATED HER LOVENOX WAS NOT HELD THIS AM, AS IS USUAL ON ECP DAYS. BMT PA WAS PRESENT & AWARE OF ALL OF THE ABOVE & GAVE OK TO PROCEED WITH ECP. SHE WILL FOLLOW UP WITH PATIENT'S REHAB FACILITY TO HOLD LOVENOX ON FUTURE ECP DAYS. PATIENT TOLERATED WELL, NO BLOOD LOSS, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167993 CELLEX KIT SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL LNR THERAKOS * B330/396

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR CHEMOTHERAPY