BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOSPAL FLAT PLATE DIALYZER

    MDR report key: 18700 · Received August 25, 1994

    Report

    Report Number
    18700
    Event Type
    Other
    Date Received
    August 25, 1994
    Date of Event
    January 11, 1994
    Report Date
    August 25, 1994
    Manufacturer
    CGH MEDICAL, INC.
    Product Code
    FJG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO ICU AFTER SUSTAINING GREATER THAN 95% TBSA FLAME BURN ON 12/04/93. PLACED ON CVVHD 12/24/93 USING THE PUMP AND FLAT PLATE DIALYZER. ON 1/11/94, FILTER HAD A SUBSTANTIAL BLOOD LEAK FOR ONE HOUR (GREATER THAN 200 CC TOTAL BLOOD LOSS). PT REQUIRED THERAPEUTIC BLOOD TRANSFUSION. BLEEDING CAME FROM HEADER AT TOP OF CELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPAL FLAT PLATE DIALYZER CONTINUOUS DIALYSIS FILTER FJG CGH MEDICAL, INC. AN69 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other IVAC INFUSION PUMP| PB 2000 VENTILATOR| HOSPAL BM22 CVVHD DIALYSIS PUMP