BEUDAMED
    FDA Adverse Event Other Summary report: N

    GAMMAMED PLUS IX

    MDR report key: 1640190 · Received March 19, 2010

    Report

    Report Number
    9612638-2010-00002
    Event Type
    Other
    Date Received
    March 19, 2010
    Date of Event
    February 19, 2010
    Report Date
    March 19, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    JAQ
    PMA / PMN Number
    K071381
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMERS MUTUAL CONCLUSION AT THIS TIME IS THAT THERE IS NO WAY TO DETERMINE IMPACT ON PTS TREATMENT. DOCUMENTATION IS AVAILABLE THAT DEMONSTRATES THAT THE USER ATTENDED TRAINING BY VARIAN AND PART OF THE TRAINING WAS THE RESTRICTIONS ON DWELL TIMES.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED VARIAN TO DISCUSS TREATMENT PLAN EXPORT FOR A BRACHYTHERAPY AFTERLOADING TREATMENT, AND IN THE COURSE OF THE DISCUSSION, REPORTED THAT THE PREVIOUS DAY, A PT'S TREATMENT WAS INTERRUPTED BY AN UNEXPECTED ERROR MESSAGE (REGARDING DWELL TIME RESOLUTION) FROM THE GAMMAMED PLUS IX CONTROL SOFTWARE. SEVERAL DWELL POSITIONS IN THE PLAN WERE 0.1 SECONDS. THE TREATMENT WAS EVENTUALLY COMPLETED AFTER DISCUSSION WITH VARIAN HELPDESK, AND MAKING APPROPRIATE ADJUSTMENTS TO THE TREATMENT PLAN. THE CUSTOMER EXPRESSED FRUSTRATION AT NOT HAVING INFO REGARDING THIS NEW FEATURE FOR ERROR CHECKING OF THE TREATMENT PLAN FOR A MINIMUM RECOMMENDED DWELL TIME. THIS FEATURE WAS IMPLEMENTED WITH VERSION 1.1 AND CUSTOMER RECEIVED RECENTLY AN UPGRADE OF THE GAMMAMED PLUS IX CONTROL SOFTWARE. IN THE ENSUING DISCUSSION OF THE ERROR MESSAGE, AND THE BASIS FOR THE ERROR CHECKING, CUSTOMER ALSO REPORTED THAT HE HAD NOT BEEN AWARE OF A DWELL TIME RESOLUTION LIMITATION OF GAMMAMED PLUS IX AFTERLOADER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMAMED PLUS IX BRACHYTHERAPY SYST., REMOTE AFTERLOADER JAQ VARIAN MEDICAL SYSTEMS PLUS IX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other