BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, PHOTOPHERESIS PROCEDURAL

    MDR report key: 2325047 · Received October 29, 2011

    Report

    Report Number
    2325047
    Event Type
    Malfunction
    Date Received
    October 29, 2011
    Date of Event
    October 14, 2011
    Report Date
    October 26, 2011
    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

    DURING THE LOADING OF THE CELL EX KIT INTO THE INSTRUMENT, THE RN NOTED SHE WAS UNABLE TO CLOSE THE DRIVE TUBE CLAMP. ON EXAMINATION OF THE KIT, SHE NOTED A PLASTIC TAB STICKING OUT FROM THE KEYED END OF DRIVE TUBE, PREVENTING CLOSURE. THE KIT WAS UNLOADED FROM THE CELL EX, THERAKOS WAS NOTIFIED, AND THE KIT WAS SENT TO BIOMED FOR EVALUATION. A NEW KIT WAS LOADED, PRIMED AND USED FOR TREATMENT. THERE WAS NO CONTACT BETWEEN THE DEFECTIVE KIT AND PATIENT AND NO HARM WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, PHOTOPHERESIS PROCEDURAL DISPOSABLE PRODUCT (DESCRIBE BELOW) LNR THERAKOS, INC. N/A Z311

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR