BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCLAREN PROTON THERAPY SYSTEM

    MDR report key: 10711862 · Received October 21, 2020

    Report

    Report Number
    3015178562-2020-00001
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    October 9, 2020
    Report Date
    October 21, 2020
    Manufacturer
    MCLAREN HEALTH CARE
    Product Code
    LHN
    PMA / PMN Number
    K160063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MCLAREN TEAM WAS ABLE TO RE-PRODUCE THE ISSUE AS FOLLOWS: CHOSE A PATIENT WITH MULTIPLE TREATMENT FIELDS, EACH WITH A LARGE NUMBER OF SPOTS PER FIELD ON THE TREATMENT DELIVERY SYSTEM. SELECT ONE OF THE TREATMENT FIELDS, WHICH HAS MANY SPOTS AND REQUIRES MORE THAN 5 SECONDS TO LOAD. LOAD THE FIELD, AND WHILE THE FIELD IS LOADING, CLOSE THE FIELD AND CONFIRM THE CLOSURE. IMMEDIATELY OPEN THE SECOND FIELD. OBSERVE THE GUI SCREEN AND COMPARE THE TARGET MU FOR DOSE DELIVERY. IN STEP 4, THE SYSTEM SHOULD NOT ALLOW FOR SELECTING A SECOND FIELD TO BE CHOSEN WHILE THE FIRST ONE IS IN PROCESS. WHEN THE SECOND FIELD WAS SELECTED, THE SCAN-DOSE REJECTED THE REQUEST WITHOUT AN ACKNOWLEDGMENT. THE TREATMENT DELIVERY SOFTWARE ERROR IS ATTRIBUTED TO IMPROPER, AND FAILURE TO STOP THE WRONG FIELD'S LOADING.

    Description of Event or Problem · 1

    DURING THE WEEKLY PHYSICS CHART REVIEW, A USER DISCOVERED THAT ONE OF THE FIELDS FOR A PATIENT RECEIVED AN INCORRECT MONITOR UNIT (MU). THE PATIENT WAS BEING TREATED FOR PROSTATE CANCER, AND THE PLAN INCLUDED THREE FIELDS. EACH FIELD CONTRIBUTED 60CGY TO THE TREATMENT VOLUME. WHEN THE THERAPIST LOADED THE RIGHT LATERAL FIELD, THE POSTERIOR FIELD WAS LOADED INSTEAD, RESULTING IN THE WRONG FIELD DELIVERY. HOWEVER, THE GUI SCREEN DISPLAYED THE CORRECT INFORMATION FOR THE FIELD NAME, GANTRY ANGLE, AND IMAGING. THIS MISHAP RESULTED IN A DOSE ERROR OF 89.8 CGY OR -50.6% TO THE TARGET FOR A SINGLE FRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180493 MCLAREN PROTON THERAPY SYSTEM PROTON THERAPY SYSTEM LHN MCLAREN HEALTH CARE N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR