BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 1961441 · Received January 6, 2011

    Report

    Report Number
    2916710-2010-00156
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K862645
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED INJURY IN THIS CASE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED A MDR IS APPROPRIATE AS THIS ISSUE IS AN APPARENT MALFUNCTION AND OCCURRENCE OF MISADMINISTRATION. AS PART OF THE INVESTIGATION, VARIAN IS FOLLOWING UP ON DETAILS OF POTENTIAL PATIENT MISADMINISTRATION. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    TWO (2) PATIENTS WERE TREATED WITH THE WRONG COLLIMATOR ROTATION COMPARED TO PLAN. THERAPIST NOTICED COLLIMATOR ROTATION MECHANICAL SCALE DID NOT MATCH PATIENT PLAN. THE COLLIMATOR ROTATION DRIVE MODULE FAILED AND WAS REPLACED. WHEN DRIVE MODULE WAS REPLACED, THE COLLIMATOR DIGITAL ROTATION READOUTS WERE CALIBRATED IN REVERSE. THE COLLIMATOR ROTATION WAS CALIBRATED BY SITES CLINICAL ENGINEER USING THE CORRECT DIRECTION AND VERIFIED BY SITES PHYSICS STAFF. PATIENT WAS TREATED WITH THE WRONG COLLIMATOR ROTATION ANGLE DURING PATIENT SETUP. THE COLLIMATOR ROTATION ANGLE DIGITAL READOUT CALIBRATION WAS PERFORMED IN REVERSE. THIS ALLOWED THE PLAN TO BE SET UP WITH NO INTERLOCKS BUT THE INCORRECT COLLIMATOR ANGLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC., ONCOLOGY SYSTEMS 2100C/D

    Patients

    Seq Age Sex Outcome Treatment
    1