BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMODIALYSIS MACHINE

    MDR report key: 16921 · Received October 18, 1994

    Report

    Report Number
    MW1003715
    Event Type
    Injury
    Date Received
    October 18, 1994
    Date of Event
    July 8, 1994
    Report Date
    October 11, 1994
    Manufacturer
    CGH MEDICAL, INC.
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE UNDERGOING HEMODIALYSIS TREATMENT IT WAS FOUND THAT THE PT PULLED OUT THE VENOUS NEEDLE FROM THE ACCESS SITE RESULTING IN BLOOD LOSS AND SUBSEQUENT CARDIAC ARREST. THE PT WAS SUCCESSFULLY RESUSCITATED. EXAMINATION OF THE HEMODIALYSIS MACHINE BY THE HOSPITAL BIOMED TECHNICIAN AND THE CO'S MFG REPRESENTATIVE REVEALED NO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYSIS MACHINE FII CGH MEDICAL, INC. C3 3C15769

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R