BEUDAMED
    FDA Adverse Event Summary report: N

    TERUFLEX

    MDR report key: 2693469 · Received August 13, 2012

    Report

    Report Number
    1722028-2012-00575
    Date Received
    August 13, 2012
    Date of Event
    July 16, 2012
    Report Date
    July 16, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    KSR
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE PRODUCT CODE 'KSR' WAS USED. INVESTIGATION: THE CUSTOMER STATED THAT SHE KNEW WHICH DEVICE CAUSED THE HEMOGLOBINURIA, SHE WAS JUST DOING HER DILIGENCE IN MENTIONING THE INCIDENT TO ALL VENDORS. THE DISPOSABLE SET WAS NOT RETURNED FOR INVESTIGATION. FOUR RETENTION SAMPLES WERE VISUALLY EXAMINED. TWO RETENTION SAMPLE BAGS WERE USED FOR SOLUTION VOLUME TESTS AND SOLUTION COMPOSITION QUANTITATIVE TESTS. NONE OF THE TESTING SHOWED ABNORMALITIES WITH THE RETENTION SAMPLES. THE DEVICE MANUFACTURING, TESTING AND INSPECTION RECORDS WERE REVIEWED FOR THIS LOT. NO ABNORMALITIES WERE FOUND. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. HEMOGLOBINURIA CAN BE CAUSED BY A PATIENT'S DISEASE STATE, HEMOLYTIC TRANSFUSION REACTION, OR HEMOLYSIS OF BLOOD UNIT PRIOR TO TRANSFUSION. HEMOLYSIS OF THE BLOOD UNIT PRIOR TO TRANSFUSION IS COMMONLY CAUSED BY THE FOLLOWING FACTORS: CHARACTERISTICS OF BLOOD - A DONOR COULD HAVE RED BLOOD CELL FRAGILITY, BACTERIAL CONTAMINATION, EXCESSIVE COOLING - BLOOD IS GRADUALLY CONGEALED AND EVENTUALLY HEMOLYZED IF IT IS COOLED BELOW -3C.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT DEVELOPED HEMOGLOBINURIA POST-PROCEDURE. THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR DEATH OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUFLEX TERUFLEX BLOOD BAG KSR TERUMO BCT 120216GB

    Patients

    Seq Age Sex Outcome Treatment
    1