BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOSPAL MEDICAL

    MDR report key: 266344 · Received February 25, 2000

    Report

    Report Number
    266344
    Event Type
    Death
    Date Received
    February 25, 2000
    Date of Event
    August 31, 1999
    Report Date
    February 22, 2000
    Manufacturer
    HOSPAL MEDICAL COBE LABS/GAMBRO HEALTHCARE
    Product Code
    FKQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING CONTINOUS VENOUS HEMO DIALYSIS ULTRAFILTRATION TREATMENTS OVER A PERIOD OF SEVERAL DAYS. PT GAINED WEIGHT DURING THIS PERIOD, 45 KG IN TOTAL. THE AMOUNTS OF FLUID CONSUMED ARE AS FOLLOWS: 19.5 LITERS ON 8/31/99, 12.5 LITERS ON 9/1/99, 31.5 LITERS ON 9/2/99, 3.0 LITERS ON 9/3/99. PT WAS CRITICALLY ILL, AND WAS SOMEWHAT COMPROMISED BY THE EXCESSIVE WEIGHT GAIN. EXPIRED 4 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPAL MEDICAL C.V.V.H. DIALYSIS FKQ HOSPAL MEDICAL COBE LABS/GAMBRO HEALTHCARE BSM/22 SC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| L