BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORTHOPAT

    MDR report key: 451611 · Received March 31, 2003

    Report

    Report Number
    1219343-2003-00003
    Event Type
    Death
    Date Received
    March 31, 2003
    Date of Event
    March 5, 2003
    Report Date
    March 31, 2003
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT. DIED POSTSURGERY, CAUSE + DATE NOT KNOWN. POST OP BLOOD SAMPLES IMPLICATED HEMOLYZED SPECIMENS, CAUSE NOT INDENTIFIED. CONCERN RAISED REGARDING POSSIBILITY OF DEVICE CONTRIBUTING TO POSSIBLE HEMOLYSIS. TWO DEVICES USED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPAT AUTORANSFUSION SYSTEM CAC HAEMONETICS CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| O