BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLATO BPS

    MDR report key: 537419 · Received July 30, 2004

    Report

    Report Number
    1121753-2004-00002
    Event Type
    Other
    Date Received
    July 30, 2004
    Date of Event
    March 31, 2004
    Report Date
    June 11, 2004
    Manufacturer
    NUCLETRON B.V.
    Product Code
    MUJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    MEDICAL CENTER REPORTED A MEDICAL EVENT. THE INCIDENT OCCURRED IN 2004. A PATIENT WAS BEING TREATED FOR PROSTATE CANCER USING AN HDR AFTERLOADER WITH A 7.315 CURIE SOURCE OF IR-192. THE TREATMENT WAS TO TAKE PLACE IN THREE FRACTIONS. THE PATIENT WAS TO RECEIVE ONE FRACTION AND TWO FRACTIONS THE NEXT DAY. THE SAME TREATMENT PLAN WAS PROGRAMMED ONCE FOR ALL THREE TREATMENT FRACTIONS USING COMPUTER PLANNING PROGRAM (NUCLETRON'S PLATO BPS). WHILE CONSTRUCTING THE TREATMENT PLAN USING THE COMPUTER PLANNING PROGRAM, THE DEFAULT SWITCH THAT CHANGES THE SOURCE POSITION CALCULATION ORIENTATION FROM CONNECTOR END TO CATHETER TIP WAS NOT ADJUSTED TO THE CORRECT ORIENTATION (CATHETER TIP) OR THE ORIENTATION TYPICALLY USED BY THE FACILITY. THIS LED TO THE SOURCES STOPPING 2CM SHORT OF THE TARGET (UPPER PORTION OF THE PROSTATE). THE TOTAL PRESCRIBED DOSE WAS NOT DELIVERED; HOWEVER, A DOSE OF 1800 CGY WAS DELIVERED TO THE WRONG LOCATION. THE RADIATION ONCOLOGIST INDICATED THAT NO DETRIMENTAL EFFECTS ARE EXPECTED. THE PATIENT IMMEDIATELY RECEIVED VERBAL AND WRITTEN NOTIFICATION OF THE MEDICAL EVENT. THE PATIENT WAS TREATED WITH EXTERNAL BEAM THERAPY WHICH DELIVERED THE TOTAL PRESCRIBED DOSE TO COMPENSATE FOR THE MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATO BPS RADIOTHERAPY TREATMENT PLANNING SYSTEM MUJ NUCLETRON B.V. 14.2.4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other