BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFENSE BLOOD STANDARD SYSTEM

    MDR report key: 2241495 · Received August 11, 2011

    Report

    Report Number
    1119523-2011-00001
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    March 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    DOD/DBSS PROJECT OFFICE
    Product Code
    MMH
    PMA / PMN Number
    BK980031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DBSS FAILED BY ALLOWING AN INCORRECT BLOOD COMPONENT OTHER THAN THE PRODUCT REQUESTED TO BE ISSUED AND TRANSFUSED. IN THIS EVENT, THE PHYSICIAN ORDERED 10 UNITS OF CRYOPRECIPITATE. THE LAB TECHNICIAN PROCESSED THE TRANSFUSION REQUEST AND INITIATED THE COMPONENT CONVERSION PROCESS (THAWING) OF 2 POOLED UNITS (1 POOLED UNIT IS 5 SINGLE UNITS) BUT COMMENTED ON THE "FATNESS" OF THE UNITS, AND WAS TOLD THAT POOLS OF 5 UNITS WOULD BE "FATTER" THAN SINGLE UNITS. THE UNITS WERE ACTUALLY CRYO-REDUCED PLASMA. UNITS WERE SET UP, ISSUED AND TRANSFUSED WITHOUT THE LAB TECHNICIAN OR TRANSFUSING NURSE NOTICING THAT THE UNITS ISSUED WERE NOT THE REQUESTED PRODUCT. ACCORDING OT THE TRANSFUSION REQUEST FORM, THE PATIENT DID NOT EXPERIENCE A TRANSFUSION REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFENSE BLOOD STANDARD SYSTEM BLOOD ESTABLISHMENT COMPUTER SOFTWARE MMH DOD/DBSS PROJECT OFFICE

    Patients

    Seq Age Sex Outcome Treatment
    1