Description of Event or Problem · 1
THIS CASE WAS RE-EVALUATED ON JULY 26, 2000 BY A CROSS-FUNCTIONAL TEAM OF "BHQ" STAFF AND DETERMINED TO BE REPORTABLE TO FDA AS AN MDR. ON NOVEMBER 3, 1999, RED CROSS DISCOVERED THAT A PROBLEM WITH A DATABASE MERGER UTILITY CAUSED THE NATIONAL BIOMEDICAL COMPUTER SYSTEM (NBCS) TO NOT APPLY "HOLDS" TO A DONOR REGISTRATION RECORD. A DONOR REGISTRATION IS PUT ON HOLD WHENEVER DONOR IDENTITY IS IN DOUBT, OR WHEN A DONOR CALLS A RED CROSS FACILITY TO PROVIDE NEW HEALTH HISTORY INFO. THIS PROBLEM OCCURRED ONLY IN THE SOUTH CAROLINA REGION, WHICH WAS INVOLVED IN A MERGER WITH THE SOUTHERN REGION. THE DATABASE MERGER UTILITY (VERSION 1.0) COMBINES RECORDS FROM TWO SEPARATE DATABASES INTO A SINGLE DATABASE. IN ORDER TO START THE MERGER, THE UTILITY MUST TEMPORARILY DEACTIVATE CERTAIN DATABASE TRIGGERS BECAUSE SUCH TRIGGERS ARE NOT ALWAYS DESIRABLE DURING A DATABASE MERGER. THE PURPOSE OF DATABASE "TRIGGERS" IS TO CAUSE CERTAIN TABLES TO BE AUTOMATICALLY UPDATED WHEN CERTAIN EVENTS OCCUR. THE DATABASE MERGER UTILITY WAS POORLY DESIGNED IN THAT IT DISABLED THE TRIGGERS, PROCEEDED WITH THE MIGRATION, AND THEN RE-ENABLED THE TRIGGERS FROM TRIGGERS IMBEDDED IN THE DATABASE MERGER UTILITY ITSELF. HOWEVER, THE REGIS TRIGGER IMBEDDED IN THE UTILITY WAS NOT THE MOST RECENT VERSION, AND THUS, THE TRIGGER DID NOT FUNCTION AS INTENDED. THE INAPPROPRIATE VERSION OF THE REGIS TRIGGER ON NBCS RESULTED IN THE INABILITY TO PLACE DONORS ON HOLD. SOUTH CAROLINA REGIONAL STAFF WERE ABLE TO IDENTIFY THIS PROBLEM BECAUSE A COMPUTER ERROR MESSAGE APPEARED WHEN ATTEMPTING TO PLACE REGISTRATIONS ON HOLD.