BEUDAMED
    FDA Adverse Event Death Summary report: N

    IBC FLOWPROBE

    MDR report key: 1565628 · Received December 28, 2009

    Report

    Report Number
    2021836-2009-00005
    Event Type
    Death
    Date Received
    December 28, 2009
    Date of Event
    November 1, 2009
    Report Date
    November 30, 2009
    Manufacturer
    GISH BIOMEDICAL, INC.
    Product Code
    KFM
    PMA / PMN Number
    K031300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GISH BIOMEDICAL RECEIVED THIS REPORT ON 11/30/09. HOWEVER, THE SOURCE PROVIDED VERY LITTLE INFORMATION AND HAS NOT RESPONDED TO ADDITIONAL REQUESTS FOR INFORMATION. SIMILAR REPORTS WERE MADE AGAINST THE IBC FLOW PUMP CAUSING HEMOLYSIS AND IN 2007 THE REPORT WAS SENT TO THE FDA INCLUDING TESTING WHICH DEMONSTRATES THAT THE IBC FLOW PUMP WAS NOT THE CAUSE OF REPORTED HEMATURIA. THE REPORT CONCLUDED THAT "SEVERAL FACTORS CONTRIBUTE TO HEMATURIA IN THE SETTING OF BYPASS SURGERY....MISUSE OF PRODUCT, DRUG INTERACTION, EMBOLI, THROMBUS FORMATION WITHIN THE SYSTEM AND HYPOVOLEMIA.

    Description of Event or Problem · 1

    THIS IS EVENT 5 OF 5, REPORTED BY OUR DISTRIBUTOR. THE CUSTOMER SAYS, THE IBC FLOW PUMP THEY USED CAUSED HEMOLYSIS AND RESULTED IN PT DEATH. RELATED REPORTS ARE: 2021836-2009-00001, 2021836-2009-00002, 2021836-2009-00003, 2021836-2009-00004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBC FLOWPROBE PUMP, BLOOD CARDIOPULMONARY BYPASS, NONROL KFM GISH BIOMEDICAL, INC. J50183-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Death