BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPAL FLAT PLATE DIALYZER

    MDR report key: 18702 · Received October 28, 1994

    Report

    Report Number
    18702
    Event Type
    Malfunction
    Date Received
    October 28, 1994
    Date of Event
    May 20, 1994
    Report Date
    October 28, 1994
    Manufacturer
    CGH MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS STATUS-POST LIVER TRANSPLANT. ON CONTINUOUS VENO-VENOUS HEMODIALYSIS. BLOOD LEAK NOTED FROM TOP OF DIALYSIS FILTER. PT REQUIRED 2 UNITS OF PACKED RED CELLS FOR TRANSFUSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other HOSPAL BM 22 CVVHD DIALYSIS PUMP| IVAC INFUSION PUMPS| PB 2000 VENTILATOR