BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM LIGHT ASSEMBLY

    MDR report key: 6553810 · Received May 5, 2017

    Report

    Report Number
    MW5069627
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    August 2, 2016
    Report Date
    August 2, 2016
    Manufacturer
    MALLINKRODT PHARMACEUTICALS
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PRIMING THE PHOTOPHERESIS DEVICE, LAMP FAILURE ALARM WAS DETECTED. ALL ATTEMPTS TO CLEAR THE ALARM FAILED. THE LAMP HAD APPROX OVER 40 HRS REMAINING. NEW LIGHT ASSEMBLY WAS INSTALLED AND THE INTENDED PROCEDURE WAS COMPLETED WITHOUT FURTHER ALARMS. DIAGNOSIS OR REASON FOR USE: CHRONIC GRAFT VERSUS HOST DISEASE. EVENT REAPPEARED AFTER REINTRODUCED: NO. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331119 THERAKOS CELLEX PHOTOPHERESIS SYSTEM LIGHT ASSEMBLY CELLEX PHOTOACTIVATION LIGHT LNR MALLINKRODT PHARMACEUTICALS CLXLGT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention CELLEX PHOTOPHERESIS SYSTEM| CELLEX PHOTPHERESIS KIT