BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX PROCEDURAL KIT

    MDR report key: 3815407 · Received May 9, 2014

    Report

    Report Number
    MW5036114
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 25, 2014
    Manufacturer
    THERAKOS INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON INSTALLATION OF THE PHOTOPHERESIS PROCEDURAL KIT, THE NURSE NOTED THE CENTRIFUGE BOWL TUBING TO BE SLIGHTING MORE THAN USUAL AFTER BEING SECURED BY THE TWO BRACKETS OF THE CENTRIFUGE BOWL ARM. THERAKOS INC. WAS CALLED TO INQUIRE ABOUT IT. BY THERAKOS RECOMMENDATION THE KIT INSTALLATION WAS NOT COMPLETED. THE KIT WAS REMOVED AND SAVED FOR THE MANUFACTURER'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281778 THERAKOS CELLEX PROCEDURAL KIT THERAKOS CELLEX PROCEDURAL KIT LNR THERAKOS INC. C303

    Patients

    Seq Age Sex Outcome Treatment
    1