BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCENTRA PROSTATE SWIFT

    MDR report key: 1299160 · Received December 4, 2008

    Report

    Report Number
    9611894-2008-00020
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    Date of Event
    April 21, 2008
    Report Date
    October 14, 2008
    Manufacturer
    NUCLETRON BV
    Product Code
    MUJ
    PMA / PMN Number
    K031158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER WAS VISITED TO FIND OUT THE CAUSE OF THE SYSTEM CRASHES. WHILE ON SITE, IT WAS DETERMINED THE CRASH WAS CAUSED BY A MEMORY OVERFLOW IN THE SOFTWARE. THE CRASH CAN BE PREVENTED BY RE-SIZING THE CATHETER LIST BEFORE THE VIEW IS SWITCHED TO OBLIQUE CUT. A REVIEW OF THE CODE REVEALED THAT THE POSITION OF THE TEMPLATE AND OTHER GEOMETRICAL STRUCTURES WAS NOT STORED FOR LARGE MODALITIES OTHER THAN ULTRASOUND, THE COMBINATION OF THESE PROBLEMS MADE IT DIFFICULT FOR THE USER TO COMPETE THE PLAN. SINCE THE PLAN IS MADE IN "REAL TIME", THE COMPOUNDING PROBLEM CAN LEAD TO POSTPONEMENT OF A PATIENT TREATMENT. A FIELD NOTICE WAS ISSUED TO USERS INFORMING THEM OF THIS COMBINED PROBLEM.

    Description of Event or Problem · 1

    DURING TREATMENT OF A PATIENT, THE SYSTEM CRASHED SIX TIMES. THIS MADE IT IMPOSSIBLE FOR THE USER TO COMPLETE THE PATIENT'S SECOND FRACTION OF BRACHYTHERAPY. THE PROBLEM WAS AGGRAVATED BY THE FACT THAT SAVED DATA COULD NOT BE RETRIEVED COMPLETELY. IMPORTANT INFORMATION CREATED WHEN PRODUCING A CT PLAN IN ONCENTRA PROSTATE ((B) (4)) IS NOT RECALLED AFTER THE PLAN HAS BEEN SAVED. THIS INCLUDES THE BASE, REFERENCE AND APEX DEFINITIONS AND IN ADDITION THE LOCATION OF THE TEMPLATE. THE CUSTOMER DOES NOT HAVE A SAVED PLAN OF THE PATIENT'S TREATMENT. THE PLANS HAVE TO BE REDEFINED TO LOAD THE CONTOURS AND IT IS POSSIBLE TO PLACE THESE IN A DIFFERENT LOCATION ON THE IMAGE SET COMPARED TO THE ORIGINAL PLAN. THE TEMPLATE ALSO HAS TO BE REPOSITIONED TO LOAD THE PLAN AND IT IS VERY DIFFICULT TO GET THIS IN EXACTLY THE SAME POSITION AS ORIGINALLY INTENDED. THE PROCESS OF REVIEWING A SAVED PLAN IS TIME CONSUMING FOR THE OPERATORS AND IT IS AN INACCURATE RECORD OF THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCENTRA PROSTATE SWIFT TREATMENT PLANNING MUJ NUCLETRON BV V 3.09

    Patients

    Seq Age Sex Outcome Treatment
    1