BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDSTRAND RX

    MDR report key: 2540909 · Received September 26, 2011

    Report

    Report Number
    2915056-2011-00021
    Event Type
    Malfunction
    Date Received
    September 26, 2011
    Date of Event
    April 11, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    KXK
    PMA / PMN Number
    K063177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: GE HEALTHCARE QUALITY ASSURANCE INVESTIGATION REPORT (B)(4)/ GE HEALTHCARE WAS MADE AWARE OF A POTENTIAL FOR INCORRECT LOADING OF RAPIDSTRAND RX NEEDLES DUE TO NON-COMPLIANCE WITH STANDARD OPERATING PROCEDURE ON THE PART OF ONE TECHNICIAN AT THE RADIOPHARMACY IN WHICH BRACHYTHERAPY IMPLANTS WERE PREPARED. FOUR INCIDENTS WERE REPORTED IN WHICH SEEDS HAD BEEN SWAPPED BETWEEN ORDERS RESULTING IN INCORRECTLY LOADED NEEDLES (MDR REPORT ID: 2915056-2011-00001, 2915056-2011-00002), OR INCORRECT CALIBRATION STRANDS BEING PROVIDED WITH THE ORDER (MDR REPORT ID: 2915056-2011-00003, 2915056-2011-00006), RESULTING IN MISLABELING OF THE DEVICE. INVESTIGATION OF THESE INCIDENTS AT THE LOADING FACILITY SHOWED THAT THE TECH HAD WORKED ON TWO ORDERS AT THE SAME TIME AND MIXED THE SEEDS BETWEEN THEM. GE HEALTHCARE REVIEWED ALL (B)(4) ORDERS THAT THE TECH COMPLETED DURING EMPLOYMENT AND IDENTIFIED (B)(4) WHERE THERE WAS THE POSSIBILITY FOR SEEDS BEING MIXED BETWEEN TWO OR MORE ORDERS. THIS WAS DETERMINED BY IT BEING POSSIBLE FOR THE TECH TO HAVE WORKED ON TWO OR MORE SAME-PRODUCT ORDERS SIMULTANEOUSLY WHERE SEEDS OF DIFFERENT ACTIVITY WERE INVOLVED. IT SHOULD BE NOTED THAT IT CANNOT BE DETERMINED THAT SEEDS WERE MIXED BETWEEN THE ORDERS, ONLY THAT THE POSSIBILITY EXISTS. MIXING SEEDS BETWEEN ORDERS IS PRESUMED TO AFFECT RADIATION EXPOSURE TO THE AREA SURROUNDING THE IMPLANT (PROSTATE GLAND, URETHRA, AND RECTUM), EITHER AN OVER-DOSE WHERE HIGHER ACTIVITY SEEDS WERE INTRODUCED INTO THE LOADED NEEDLES CARRYING INCREASED RISK OF RADIATION SIDE-EFFECTS, OR UNDER-DOSE WHERE LOWER ACTIVITY SEEDS WERE INTRODUCED INTO THE LOADED NEEDLES CARRYING RISK OF SUB-OPTIMAL TREATMENT OF THE TUMOR. THE ORDERED SEED ACTIVITY AND TREATMENT PLAN FOR EACH OF THE (B)(4) PTS WAS REVIEWED AGAINST THE SEED ACTIVITY IN THE ORDER RELEVANT TO THE POSSIBLE MIX-UP. WORST-CASE SCENARIO, 100% SWAP, WAS ASSUMED AND THE CONSEQUENT OVER-DOSE OR UNDER-DOSE CALCULATED. GE HEALTHCARE RISK ASSESSMENT CONCLUDED THAT, FROM A MEDICAL VIEWPOINT, THE RISK OF SERIOUS INJURY OR DEATH AS A RESULT OF A RECURRENCE OF SUCH MISLABELING IS REMOTE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A MALE PT WAS IMPLANTED WITH 65 RAPIDSTRAND RX SEEDS OF 12.58 MBQ (0.340 MCI ACTIVITY ON IMPLANT DATE) FOR BRACHYTHERAPY OF PROSTATE CANCER. PER (B)(4), THE SEEDS MAY HAVE BEEN MIXED WITH ANOTHER SEEDS ORDERS OF 16.06 MBQ (0.434 MCI) AND/OR 12.42 MBQ (0.336 MCI), RESULTING IN A POTENTIAL RADIATION OVER-DOSE OR UNDER-DOSE RESPECTIVELY (UNDER-DOSE NOT SIGNIFICANT PER MODEL). TO DATE, NO ADVERSE EXPERIENCE HAS BEEN NOTIFIED TO THE COMPANY FOR THIS PT. THE ORDERED SEED ACTIVITY AND TREATMENT PLAN FOR THIS PT WAS REVIEWED BY THE GE HEALTHCARE MEDICAL GROUP AGAINST THE SEED ACTIVITY IN THE ORDER RELEVANT TO THE POSSIBLE MIX-UP. WORST-CASE SCENARIO, 100% SWAP, WAS ASSUMED AND THE POTENTIAL OVER-DOSE OR UNDER-DOSE CALCULATED. GE HEALTHCARE HAS NOTIFIED THE PHYSICIAN WHO PERFORMED THE SEED IMPLANT IN WRITING AND BY TELEPHONE AND IS FOLLOWING UP FOR FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDSTRAND RX RADIONUCLIDE BRACHYTHERAPY SOURCE KXK GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1