BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONCENTRA BRACHYTHERAPY

    MDR report key: 2757787 · Received September 18, 2012

    Report

    Report Number
    9611894-2012-00005
    Event Type
    Other
    Date Received
    September 18, 2012
    Date of Event
    August 20, 2012
    Report Date
    September 18, 2012
    Manufacturer
    NUCLETRON
    Product Code
    MUJ
    PMA / PMN Number
    K081281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE IS NOT REPRODUCEABLE. THE MFR PRESCRIBED QA CHECK SHOULD HAVE PREVENTED THE EVENT. WE BELIEVE THIS INCIDENT ALSO QUALIFIES THE EVENT AS AN ABNORMAL OCCURRENCE.

    Description of Event or Problem · 1

    AN ONCENTRA BRACHY PLAN WAS CORRECTED BY THE USER BEFORE THE FIRST FRACTION AND NOT CHECKED. THIS PLAN CONTAINED AN INCORRECT TOTAL DOSE OF 600 CGY (RAD) VERSUS THE PRESCRIBED DOSE 340 CGY (RAD). THIS RESULTED IN AN OVERDOSE DURING THE FIRST FRACTION OF APPROX 76.5% AS PRESCRIBED BY THE PLANNING SOFTWARE. THE ROOT CAUSE IS NOT CLEAR AND THE ISSUE COULD NOT BE REPLICATED, BUT IT SEEMS LOGICAL THAT IT IS RELATED TO A SOFTWARE ISSUE. CONSEQUENTLY FACILITY STAFF ALSO FAILED TO COMPLETE A MFR REQUIRED QA CHECK WHICH MAY HAVE ALERTED THE AUTHORIZED USER TO THE DOSAGE DIFFERENCE PRIOR TO TREATMENT. THE PT WAS NOTIFIED ON THE SAME DAY, WHILE THE REFERRING PHYSICIAN WAS NOTIFIED THE FOLLOWING DAY. THE TREATING PHYSICIAN ANTICIPATES NO EFFECT TO THE PT. WE BELIEVE THIS INCIDENT ALSO QUALIFIES THE EVENT AS AN ABNORMAL OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCENTRA BRACHYTHERAPY TREATMENT PLANNING PACKAGE MUJ NUCLETRON #4.1

    Patients

    Seq Age Sex Outcome Treatment
    1