BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPIDSTRAND RX

    MDR report key: 3388265 · Received September 12, 2013

    Report

    Report Number
    2915056-2013-00059
    Event Type
    Other
    Date Received
    September 12, 2013
    Report Date
    June 3, 2013
    Product Code
    KXK
    PMA / PMN Number
    K063177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: ERROR BY CONTRACT MANUFACTURER COMPUTER OPERATOR WHEN ENTERING THE TREATMENT PLAN DETAILS INTO THE ORDER FULFILLMENT SOFTWARE. (E.G. ADDITIONAL LOT# 130247A). EVALUATION SUMMARY: PRELIMINARY EVALUATION RESULTS: THIS FAILURE OCCURRED BECAUSE THE PATIENT DOSE PLAN PROVIDED WITH EACH ORDER WAS INCORRECTLY ENTERED BY GE HEALTHCARE'S CONTRACT MANUFACTURER, (B)(4), INTO THEIR ORDER FULFILLMENT SOFTWARE SYSTEM (SYSTEM OPERATOR ERROR) PRIOR TO ASSEMBLY. THE AFFECTED USER FACILITY PROVIDES PATIENT-SPECIFIC NEEDLE LOADING PLANS GENERATED FROM A (B)(4) PLATFORM. THIS PLATFORM GENERATES AND DISPLAYS THE LOADING PLAN AS INDIVIDUAL SEALED SOURCE IMPLANT NEEDLES PLAN IN THE OPPOSITE ORDER (FROM RIGHT TO LEFT AND NOT LEFT TO RIGHT) TO MOST COMMERCIALLY AVAILABLE SYSTEMS. THIS WAS NOT TAKEN INTO ACCOUNT BY THE NEEDLES BEING INCORRECTLY LOADED AS DETAILED BELOW. PATIENT DOSE PLANT CONSISTED OF 83 IODINE-125 BRACHYTHERAPY SOURCES TO BE LOADED IN TO 25 IMPLANT NEEDLES. SIX NEEDLES HAD ASYMMETRICAL LOADING PLANS AND WERE INCORRECTLY LOADED. THE LOADING PLAN IN THE OTHER 19 NEEDLES WAS SYMMETRICAL, THEREFORE,9 NOT AFFECTED. THE CUSTOMER (BOTH DOCTORS AND PHYSICS DEPARTMENT) WAS ADVISED IN WRITING AND BY TELEPHONE BY GE HEALTHCARE CUSTOMER SERVICE, LOCAL SALES REPRESENTATIVE, AND THE GE HEALTHCARE MEDICAL DIRECTOR ON THE DAY BEFORE THE IMPLANT DATE. THE CUSTOMER MADE NECESSARY ADJUSTMENTS FOR THE ORDER WHICH WAS SUBSEQUENTLY IMPLANTED SUCCESSFULLY ACCORDING TO THE TREATMENT PLAN.

    Description of Event or Problem · 1

    ON (B)(4) 2013, GE HEALTHCARE RECEIVED INFORMATION CONCERNING A DEVICE MALFUNCTION WITH NO ASSOCIATED ADVERSE EVENT. AN ORDER OF RAPIDSTRAND RX WAS SENT TO A USER FACILITY WITH INCORRECTLY LOADED BRACHYTHERAPY IMPLANT NEEDLES (ERROR IN THE CONFIGURATION OF LOADED SEEDS). BEFORE IMPLANTATION, THE FACILITY WAS ADVISED BY GE HEALTHCARE OF THE ERROR AND WAS SUBSEQUENTLY ABLE TO CORRECTLY CONFIGURE THE IMPLANT, WHICH WAS SUCCESSFULLY CARRIED OUT ACCORDING TO THE TREATMENT PLAN. THIS MALFUNCTION WAS ASSESSED AS HAVING THE POTENTIAL TO CAUSE DEATH OR SERIOUS INJURY SHOULD IT RECUR. QUALITY ASSURANCE INVESTIGATION (B)(4) IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458476 RAPIDSTRAND RX RADIONUCLIDE BRACHYTHERAPY SOURCE KXK 130254A

    Patients

    Seq Age Sex Outcome Treatment
    1