BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SURGISCREEN

    MDR report key: 660989 · Received December 29, 2005

    Report

    Report Number
    2250051-2005-50578
    Event Type
    Malfunction
    Date Received
    December 29, 2005
    Date of Event
    November 26, 2005
    Report Date
    December 29, 2005
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT SAMPLE CONTAINING ANTI-LEA DID NOT REACT WITH 0.8% SURGISCREEN LOT 8SS375. CUSTOMER REPORTED THAT TWO UNITS WERE TRANSFUSED AND DURING TRANSFUSION OF THE SECOND UNIT THE PT EXPERIENCED A TRANSFUSION REACTION. THE PT'S SYMPTOMS INCLUDE CHILLS, TACHYCARDIA, INCREASED PULSE AND INCREASED RESPIRATION. THE TRANSFUSION OF THE SECOND UNIT WAS STOPPED. A REPEAT ANTIBODY SCREEN WAS PERFORMED ON THE PT'S SAMPLE AT ANOTHER FACILITY USING 0.8% SURGISCREEN LOT 8SS375. A POSITIVE RESULT WAS OBTAINED WITH CELL 3, THE REACTION WAS 2+. A REFERENCE LAB ASSOCIATED WITH THE CUSTOMER SITE HAS INDICATED THAT THE PT'S SAMPLE CONTAINED BOTH ANTI-LEA AND ANTI-LEB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SURGISCREEN REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. NA 8SS375

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other