BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUSPLUS

    MDR report key: 6961204 · Received October 19, 2017

    Report

    Report Number
    3000256071-2017-00003
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    September 27, 2017
    Report Date
    September 27, 2017
    Manufacturer
    IBA (ION BEAM APPLICATIONS)
    Product Code
    LHN
    PMA / PMN Number
    K082416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY IS PROVIDED.

    Description of Event or Problem · 1

    DESCRIPTION OF THE EVENT: IBA HAS BEEN INFORMED THAT, ON (B)(6) 2017, DURING A PATIENT TREATMENT, THE RANGE SHIFTER WAS NOT CORRECTLY ALIGNED ON THE RAILS. A RANGE SHIFTER IS USED IN PENCIL BEAM SCANNING TO SHIFT THE DOSE DISTRIBUTION IN THE TARGETED AREA IN THE PATIENT. TREATMENT FIELDS WERE DELIVERED WITH A SLIGHTLY ANGLED RANGE SHIFTER. AFTER THE DELIVERY OF THE TREATMENT, WHILE THE GANTRY WAS AT 340°, THE PATIENT HIT THE RANGE SHIFTER WHILE GETTING SITTED. THE RANGE SHIFTER (23 POUNDS) THEN FELL OUT AND GRAZED THE PATIENT FACE. IMPACT OF THE EVENT ON THE PATIENT: THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT OF THE HOSPITAL FOR EVALUATION. THE PATIENT WAS RELEASED WITH NO INJURIES. THE HOSPITAL EVALUATED THE IMPACT OF THE SLIGHTLY ANGLED RANGE SHIFTER ON BEAM PROPERTIES IN TREATMENT FIELD TO LESS THAN 1 MM IN WATER-EQUIVALENT-THICKNESS CHANGE FOR THE TREATMENT FIELD, THEREFORE WELL WITHIN THEIR MARGIN USED IN TREATMENT PLANNING. IBA IS PROACTIVELY REPORTING THIS EVENT DUE TO THE HEAVY WEIGHT OF THE RANGE SHIFTER AND SIGNIFICANT IMPACT IT COULD HAVE IF THERE WAS A NEW OCCURRENCE. EVALUATION SUMMARY: INVESTIGATION DEMONSTRATED THAT THE RANGE SHIFTER CAN BE INSERTED WITH ONLY THE UPPER RAIL IN THE GUIDE, THE LOWER RAIL RESTING JUST OUTSIDE THE GUIDE (SEE ATTACHMENT). WITH THIS CONFIGURATION, THE LOCKING PIN WILL LOCK THE RANGE SHIFTER INTO PLACE AND THE INSERTION PINS WILL ALSO BE PUSHED IN (SEE ATTACHMENTS). HOWEVER, WITH MINIMAL OUTWARD PRESSURE, THE RANGE SHIFTER CAN BE PULLED OUT OF THE HOLDER AND FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741771 PROTEUSPLUS PROTON THERAPY SYSTEM LHN IBA (ION BEAM APPLICATIONS) PROTEUS 235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other