BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARISEED

    MDR report key: 2162272 · Received July 8, 2011

    Report

    Report Number
    1124791-2011-00001
    Event Type
    Other
    Date Received
    July 8, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    KXK
    PMA / PMN Number
    K030534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THIS EVENT/NEAR MISS WAS HUMAN/USER ERROR, AS REPORTED BY THE CUSTOMER. RESULTS: INVESTIGATION OF THIS HAZARD HAS DETERMINED THAT: THE VARISEED DEVICE FUNCTIONED AS DESIGNED AND PER SPECIFICATION. HUMAN ERROR CANNOT BE COMPLETELY ELIMINATED. THE RISK TEAM CONSIDERED ELIMINATING THE USE OF MCI, BUT THERE WOULD BE CONSIDERABLE USER DISSATISFACTION DUE TO ITS HISTORICAL USE AND IT STILL MAY NOT ELIMINATE THE HAZARD ENTIRELY AS A USER MAY STILL ASSUME THE WRONG UNITS. APPROXIMATELY 1800 INSTALLED BASE IN USE. THERE HAVE BEEN TWO SIMILAR REPORTS SINCE 2008. ENGINEERING ANALYSIS SHOWS THAT ADEQUATE MITIGATIONS ARE IN PLACE. LITERATURE REVIEW SHOWS THE IMPROBABILITY OF THE PATIENT HARM FOR A CRITICAL INJURY (PERMANENT PARTIAL DISABILITY, I.E. RECTAL FISTULA). THOUGH THERE WAS NO MALFUNCTION OF THE VARISEED DEVICE THAT CONTRIBUTED TO OR COULD POTENTIALLY CONTRIBUTE TO OR RESULT IN SERIOUS INJURY, VARIAN HAS MADE THE DECISION TO INITIATE A CAPA TO DETERMINE POSSIBLE FURTHER MITIGATIONS FOR MINIMIZING THE POTENTIAL FOR HUMAN/USER ERROR. ANY FURTHER CORRECTIVE ACTIONS AS A RESULT OF THIS ISSUE WILL BE ADDRESSED IN VARIAN'S CAPA PROCESS. THE CUSTOMER HAS REPORTED THAT THEY HAVE TIGHTENED UP THEIR CHECKING PROCEDURE SO THAT THEY NOW CHECK FOR THE MCI AND U VALUES USED INSTEAD OF JUST MCI. NO FURTHER FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER PLANNED FOR A BOOST PROSTATE PERMANENT SEED IMPLANT TO GIVE THE REQUIRED DOSE COVERAGE FOR A SEED ACTIVITY OF 0.420U (0.331MCI). HOWEVER, THE USER SITES TYPICAL PLANNING PROCESS FOR A FULL TREATMENT IS 0.420MCI (0.533U). THE SEEDS ORDERED BY THE CUSTOMER FROM ONCURA, WERE FOR THE USER SITES TYPICAL ACTIVITY OF 0.420 MCI, I.E. 27% HOTTER THAN THEY HAD DONE THE PLAN FOR. THE ERROR IN THE SEED ACTIVITY WAS SPOTTED BY THE USERS IN THE MORNING BEFORE THE IMPLANT IN THE AFTERNOON. THEY SPENT THE MORNING RE-PLANNING THE PATIENT FROM SCRATCH USING THE CORRECT SEED ACTIVITY AND PRE-LOADED NEEDLES ALREADY SUPPLIED BY (B)(4). FORTUNATELY, THEY WERE ABLE TO ACHIEVE AN ACCEPTABLE DOSE DISTRIBUTION USING FEWER, HIGHER ACTIVITY PRE-LOADED NEEDLES. USER STATED THAT THE ISSUE WAS A PRETTY BASIC ERROR ON THEIR PART AND THEIR PLAN CHECKING PROCEDURES HAVE BEEN UPDATED. NO SERIOUS INJURY OR MISADMINISTRATION IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARISEED SOURCE, BRACHYTHERAPY, RADIONUCLIDE KXK VARIAN MEDICAL SYSTEMS H62

    Patients

    Seq Age Sex Outcome Treatment
    1