BEUDAMED
    FDA Adverse Event Other Summary report: N

    NBCS-NATIONAL BIOMEDICAL COMPUTER SYSTEM

    MDR report key: 284634 · Received June 30, 2000

    Report

    Report Number
    1124939-2000-00004
    Event Type
    Other
    Date Received
    June 30, 2000
    Date of Event
    May 31, 2000
    Report Date
    June 30, 2000
    Manufacturer
    AMERICAN NATIONAL RED CROSS
    Product Code
    MMH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING A REVIEW ON MAY 31, 2000 OF A USER REQUEST FOR GUIDANCE, THE USER FACILITY DISCOVERED A PROBLEM IN THE NATIONAL BIOMEDICAL COMPUTER SYSTEM (NBCS) THAT COULD RESULT IN DONOR INFO NOT BEING CHECKED PRIOR TO SHIPPING A PRODUCT. THE PROBLEM IS LIMITED TO PRODUCTS THAT THE REGION PRODUCED AND SHIPPED, BUT THEN, WHEN THEY WERE RETURNED TO THE REGION, THEY WERE "IMPORTED" RATHER THAN "RETURNED." THE RESULT OF A REGION IMPORTING ITS OWN UNITS IS THAT THE NBCS TREATS THE IMPORTED UNIT AS A NEW UNIT, AND DOES NOT LINK IT WITH THE EXISTING DONOR INFO. THEREFORE, CHANGES TO THAT DONOR RECORD (POST-DONATION INFO) WILL NOT BE CONSIDERED WHEN THE PRODUCT IS RE-SHIPPED. THIS COULD RESULT IN AN UNACCEPTABLE UNIT BEING RELEASED. CASE #211339 WAS OPENED IN THE USER SUPPORT CALL-TRACKING TOOL CLARIFY AS A POTENTIAL HAZARD FOR THIS INVESTIGATION. THE INVESTIGATION REVEALED THAT REGIONS HAVE THE ABILITY TO IMPORT THEIR OWN COMPONENTS BECAUSE THE "IVAL" FOR THE IMPORT_INHOUSE_INVENTORY PARAMETER IN THE CDIS SYSPARAM TABLE IN NBCS WAS SET TO "1" (ONE) INSTEAD OF "0" (ZERO). WHEN THE TABLE VALUE IS SET TO "0" A REGION IS PREVENTED FROM IMPORTING ITS OWN BLOOD COMPONENTS AND RECEIVES A MESSAGE STATING: "CANNOT IMPORT FROM YOUR OWN CENTER...." THIS PARAMETER HAD BEEN SET TO "1" DURING THE INITIAL MIGRATION OF THE REGIONS TO NBCS. THIS ALLOWED MIGRATING REGIONS TO IMPORT COMPONENTS THAT THEY HAD IN INVENTORY AND POPULATE THE NBCS DATABASE WITH THE REGION'S EXISTING PRODUCTS. REQUIREMENT 2.6.17.7.5 FOR NBCS STATES THAT, "THE SYSTEM SHALL PREVENT A REGION FROM IMPORTING ITS OWN COMPONENTS EXCEPT DURING MIGRATION ACTIVITIES." DURING THE INVESTIGATION, IT WAS DETERMINED THAT SPECIAL INSTALLATION PROCEDURE (SIP) 1044 COULD BE USED TO CHANGE THE PARAMETER FROM "1" TO "0."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NBCS-NATIONAL BIOMEDICAL COMPUTER SYSTEM SOFTWARE, BLOOD-BANK (STAND ALONE PRODUCTS) MMH AMERICAN NATIONAL RED CROSS NA VERSION 1.1 TO 1.4.3

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other