BEUDAMED
    FDA Adverse Event Summary report: N

    ONCENTRA BRACHY TPS

    MDR report key: 4356455 · Received December 23, 2014

    Report

    Report Number
    9611894-2014-00005
    Date Received
    December 23, 2014
    Date of Event
    November 26, 2014
    Report Date
    March 19, 2015
    Manufacturer
    NUCLETRON
    Product Code
    MUJ
    PMA / PMN Number
    K132816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION RESULTS: THE PROBLEM COULD NOT BE REPRODUCED IN ONCENTRA BRACHY. HOWEVER CHANNEL NUMBERING IN THE CASE EXPLORER WAS NOT UPDATED CORRECTLY. CHANNEL NUMBERING IS NOT AVAILABLE IN THE EXPORTED TREATMENT PLAN AFTER EXPORT OF THE TREATMENT PLAN TO TCS IN PROPRIETARY FORMAT. PROPRIETARY PLAN FORMATS SHOULD BE AVOIDED SINCE IT DOES NOT INCLUDE CATHETER NUMBERING INFORMATION. EXPORT IN DICOM FORMAT IS HANDLED CORRECTLY AS THIS WILL NOT AFFECT THE CHANNEL NUMBERING. ELEKTA ADVICES TO EXPORT THE TREATMENT PLAN IN DICOM FORMAT AS THE PROBLEM DOES NOT OCCUR WHEN EXPORTING THE PLAN IN DICOM FORMAT. THE LATEST RELEASE OF TCS NOW FULLY SUPPORTS DICOM PLANS, WHICH MEANS THAT THE TRANSFERRING OF PROPRIETARY PLANS IS NO LONGER NECESSARY. ALWAYS EXECUTE THE EXTRA CHECK CABLE RUN IN TCS BEFORE START OF THE TREATMENT. THIS WILL RESULT IN AN ERROR MESSAGE WHEN TRANSFER TUBES ARE NOT INSERTED INTO THE CORRECT AFTERLOADER CHANNEL. MANUFACTURER'S RECOMMENDED ACTION: ERROR MESSAGES ARE IN PLACE, INDICATING AN INCORRECT USE OF: TOTAL NUMBER OF TRANSFER TUBES. MISSING TRANSFER TUBES IN THE AFTERLOADER CHANNELS. ALWAYS EXECUTE THE EXTRA CHECK CABLE RUN IN TCS BEFORE START OF THE TREATMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT OCB 4.3 CHANGED TREATMENT CHANNELS AFTER DELETING A CATHETER, LEADING TO THE MISTREATMENT OF A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845624 ONCENTRA BRACHY TPS SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ NUCLETRON

    Patients

    Seq Age Sex Outcome Treatment
    1 Other