BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOURCE POSITION SIMULATOR

    MDR report key: 2933147 · Received January 25, 2013

    Report

    Report Number
    9611894-2013-00002
    Event Type
    Other
    Date Received
    January 25, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    NUCLETRON
    Product Code
    JAQ
    PMA / PMN Number
    K061354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING MEDICAL DEVICE REPORT IS BEING SUBMITTED TO THE FDA, TO REPLACE REPORT NUMBER (B)(4). WE INADVERTENTLY REPORTED THE 'DATE OF REPORT' AS (B)(4) 2012, WHICH SHOULD HAVE BEEN (B)(4) 2013. ALSO, THE ACTUAL MFR REPORT NUMBER SHOULD HAVE BEEN (B)(4). THIS HAS BEEN THE ONLY CHANGE TO THIS REPORT.

    Description of Event or Problem · 1

    A PARAMETER (DISTAL END OF THE CATHETER) WAS ENTERED INCORRECTLY IN THE HDR CONTROL PANEL, RESULTING IN A DOSE TO THE SKIN OF THE PATIENT OF AROUND 160 CGRAY. THE INTENDED DOSE WAS 160-170 CGY TO A DIFFERENT TREATMENT SITE. THE INTENDED TARGET WAS AN ALMOST SPHERICAL VOLUME LOCATED IN THE RIGHT BREAST. THE SKIN THAT WAS EXPOSED IS LOCATED IN THE RIGHT BREAST, AT THE ENTRANCE OF THE DEVICE A MULTI-LUMEN MAMMOSITE CATHETER. THE CLOSEST ORGAN AT RISK IS THE RIGHT LUNG. ACCORDING TO THE HOSPITAL, THE PATIENT IS FINE AND WAS INFORMED OF THIS. THE EVENT WAS BEING REPORTED UNDER 10 CFR 35 BY THE HOSPITAL. HOSPITAL STATES THAT EITHER THE SOURCE POSITON STIMULATOR VALUES WERE RECORDED INCORRECTLY OR NOT ENOUGH FORCE WAS USED WHEN PUSHING THE SOURCE POSITON SIMULATOR OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36133 SOURCE POSITION SIMULATOR HDR REMOTE AFTERLOADER ACCESSORY JAQ NUCLETRON 111.096

    Patients

    Seq Age Sex Outcome Treatment
    1 Other