BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAKOS CELLEX SYSTEM

    MDR report key: 4202564 · Received September 18, 2014

    Report

    Report Number
    2523595-2014-00239
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF LOT C120 WAS CONDUCTED AND THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET RELEASE REQUIREMENTS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, SMOKE-DIRECT/INDIRECT, AND NO TRENDS WERE DETECTED. THERE WAS NO CAPA FOR THIS COMPLAINT CATEGORY. THE ASSESSMENT IS BASED ON INFO AVAILABLE AT THE TIME OF THE INVESTIGATION. ANALYSIS OF THE SMART CARD DATA IS STILL IN PROGRESS AT THE TIME OF THIS REPORT, THEREFORE FINAL INVESTIGATION FINDINGS ARE STILL PENDING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHITE SMOKE COMING OUT OF THE PHOTOACTIVATION DOOR AT THE END OF PHOTOACTIVATION. LAMP LIFE LEFT: 73.4 HRS. NO ALARMS OCCURRED. TREATMENT WAS SUCCESSFULLY COMPLETED. CUSTOMER REPORTED THAT WHEN THE EVENT OCCURRED THEY COULD HEAR A "SMASHING NOISE" AND THEN THERE WAS WHITE SMOKE COMING OUT OF THE INSTRUMENT. THE NURSES WERE WORRIED THE LAMPS WERE NOT FUNCTIONAL, CLINICAL SERVICES SPECIALIST (CSS) INFORMED THAT IF THE LAMPS WERE BROKEN THERE WOULD BE AN ALARM AND THEY WOULD NOT BE ABLE TO PROCEED. CSS ADVISED THE CUSTOMER TO MONITOR THE MACHINE IN THE FOLLOWING DAYS AND CALL BACK IN CASE OF PROBLEMS. THE NEXT DAY, THE CUSTOMER REPORTED THAT THE MACHINE WAS WORKING NORMALLY, NO ALARMS OCCURRED. THE PT WAS REPORTED TO BE FINE. THERE WAS NO HEMOLYSIS AND NO BLOOD LEAK. SMARTCARD DATA WAS RETRIEVED ON (B)(4) 2014. THERE WAS NO SERVICE ORDER GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580880 THERAKOS CELLEX SYSTEM CELLEX LNR THERAKOS, INC. C120-KIT

    Patients

    Seq Age Sex Outcome Treatment
    1