BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDR BRACHTHERAPY SYSTEM

    MDR report key: 7595874 · Received June 13, 2018

    Report

    Report Number
    7595874
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    April 20, 2018
    Report Date
    May 22, 2018
    Manufacturer
    ELEKTA, INC.
    Product Code
    KXK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REQUIRED SOFTWARE UPGRADE FOR THE TREATMENT CONTROL STATION (TCS) OF THE HDR IR-192 BRACHYTHERAPY SYSTEM WAS PERFORMED BY THE SERVICE ENGINEER FROM ELEKTA/NUCLETRON, INC. AFTER COMPLETING THE UPGRADE, THE ENGINEER INFORMED THAT ALL PRIOR PATIENT TREATMENTS WERE TRANSFERRED. UPON USING THE HDR SYSTEM 4 DAYS LATER FOR TREATING THE PATIENT, THERE WAS CONFUSION AS TO HOW MANY TREATMENT FRACTIONS HAD BEEN DELIVERED. APPARENTLY, HER TREATMENT HAD NOT BEEN TRANSFERRED DURING THE TCS SOFTWARE UPGRADE, AND IT APPEARED SHE ONLY HAD RECEIVED 3 TREATMENT FRACTIONS INSTEAD OF 4. EXAMINING THE DEPARTMENTAL RECORD OF TREATMENT DELIVERY, IT WAS CLEAR THAT 4 TREATMENTS HAD BEEN DELIVERED AND THAT THE TCS RECORD WAS NOT UP-TO-DATE. THEREFORE, THE PATIENT'S 5TH (AND FINAL) TREATMENT FRACTION WAS PROPERLY DELIVERED 4 DAYS POST UPGRADE. THE TCS MANUFACTURER AND ENGINEER WERE CONTACTED BY THE REPORTER TO ALERT THEM OF THE ISSUE. THIS WAS LOGGED WITH ELEKTA. ELEKTA RESPONDED EARLY THE FOLLOWING MONTH THAT THIS ISSUE HAD NOT BEEN PREVIOUSLY REPORTED, AND THAT THEIR PROCEDURES FOR TCS UPGRADE ARE SUFFICIENT. THIS EVENT WAS LOGGED SOON AFTER THE SAFETY MEETING THAT MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438287 HDR BRACHTHERAPY SYSTEM SOURCE, BRACHYTHERAPY, RADIONUCLIDE KXK ELEKTA, INC. 11731

    Patients

    Seq Age Sex Outcome Treatment
    1