BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFENSE BLOOD STANDARD SYSTEM (DBSS)

    MDR report key: 558823 · Received November 10, 2004

    Report

    Report Number
    1119523-2004-00001
    Event Type
    Injury
    Date Received
    November 10, 2004
    Date of Event
    November 8, 2002
    Report Date
    November 5, 2004
    Manufacturer
    DOD/DMLSS/DBSS
    Product Code
    MMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUBJECT PT'S FIRST TRANSACTION IN DBSS WAS IN 10/99. A TYPE AND CROSSMATCH WAS ORDERED. PT WAS O POST WITH A POSTIVE ANTIBODY SCREEN. PT TESTED FOR BOTH ANTI-E AND ANTI-K. ANTIBODIES ANTI-CW, ANTI-KPA, ANTI-JSA AND ANTI-LUA WERE NOT RULED OUT AT THAT TIME. ALL RESULTS WERE ENTERED AND VERIFIED IN DBSS. CALLER ALLEGES THAT DBSS DID NOT UPDATE THE PT DEMOGRAPHICS SPECIAL INSTRUCTION BOX WITH THE ANTIBODY WARNING DURING THIS TRANSACTION. TWO PRE-SCREENED UNITS OF PRBCS WERE TRANSFUSED AT THAT TIME. PT WAS AGAIN ADMITTED IN 2002. A CROSSMATCH WAS ORDERED FOR THREE UNITS OF PRBCS. PT ANTIBODY SCREEN WAS NEGATIVE AT THAT TIME. SINCE DBSS DID NOT INDICATE THE PT HAD A HISTORY OF A POSITIVE ANTIBODY SCREEN, SITE ISSUED AND TRANSFUSED THREE UNITS OF UNSCREENED PRBCS. IN 02/03, PT WAS AGAIN ADMITTED. UNITS WERE EMERGENCY RELEASED AND TRANSFUSED DUE TO THE SITE'S INABILITY TO IDENTIFY ALL ANTIBODIES PRESENT IN THE PT'S SERUM. A BLOOD SAMPLE WAS SENT TO A REFERENCE LABORATORY FOR FURTHER TESTING. THIS SPECIMEN CAME BACK POSITIVE FOR ANTI-E, ANTI-K, AND ANTI-JKA (FYB WAS NOT RULED OUT). NOTE: DBSS NOW DISPLAYS AN ANTIBODY WARNING BASED UPON THE MOST CURRENT ANTIBODY IDENTIFICATION INFORMATION ENTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFENSE BLOOD STANDARD SYSTEM (DBSS) BLOOD ESTABLISHMENT COMPUTER SOFTWARE MMH DOD/DMLSS/DBSS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening