SEED ACTIVITY FOR BRACHYTHERAPY ORDER WAS ENTERED USING THE WRONG UNITS CAUSING A DISCREPANCY BETWEEN THE ORDERED SEED STRENGTH AND THE SEED STRENGTH THAT WAS DELIVERED. THE ERROR WAS DETECTED AT THE USER FACILITY PRIOR TO USE AND REPORTED TO THE MANUFACTURER. A REPLACEMENT ORDER WAS SHIPPED TO THE USER AND THE IMPLANT WAS PERFORMED AS ORIGINALLY SCHEDULED. HAD THE SEEDS BEEN IMPLANTED, THE PT WOULD HAVE RECEIVED AN UNDERDOSE OF 23% THAT WOULD HAVE REQUIRED ADD'L TREATMENT FOR COLD SPOTS.
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Patient 1
UPON REVIEW OF THE ORDER FORM, IT WAS CONFIRMED THAT THE UNITS OF THE ACTIVITY FOR THE THERASEED ORDERED BY THE CUSTOMER WERE NOT CONVERTED CORRECTLY DURING THE ORDER ENTRY PROCESS. THERAGENICS RECEIVED THE PD-103 ORDER IN MILLICURIE (MCI) UNITS. IN ORDER TO PROVIDE THE CORRECT ACTIVITY, THE MCI UNITS MUST BE CONVERTED TO UNITS (U) UNITS. THE CUSTOMER SVC REP FAILED TO CONVERT THE UNITS AND ENTERED THE ORDER UNDER THE WRONG ACTIVITY. THE ERROR WAS NOT DETECTED DURING THE CUSTOMER'S ORDER CONFIRMATION PROCESS. UPON QA REVIEW OF THE RECEIVED ORDER AT THE USER FACILITY, THE DISCREPANCY WAS DETECTED PRIOR TO IMPLANT. A REPLACEMENT ORDER WAS SHIPPED TO THE FACILITY WITH THE CORRECT ACTIVITY AND THE IMPLANT WAS COMPLETED. THE PT WAS NOT AFFECTED. CORRECTIVE ACTIONS ARE CURRENTLY BEING IMPLEMENTED AT THERAGENICS TO PREVENT REOCCURRENCE. THE MALFUNCTION WAS CAUSED BY FILLING THE SEED ORDER WITH A HIGHER THAN REQUESTED ACTIVITY, WHICH COULD HAVE RESULTED IN AN UNDERDOSE.