BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPAL HEMOSPAL FILTER

    MDR report key: 18703 · Received October 28, 1994

    Report

    Report Number
    18703
    Event Type
    Malfunction
    Date Received
    October 28, 1994
    Date of Event
    May 27, 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 X 3, WITH REJECTION. WAS ON CONTINUOUS VENO-VENOUS HEMODIALYSIS. BLOOD LEAK NOTED FROM TOP OF DIALYSIS FILTER, IN HEADER. PT HAD TRANSFUSION OF ONE UNIT PACKED RED BLOOD CELLS. SYSTEM CHANGED, WITH LOSS OF 250 CC OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPAL HEMOSPAL FILTER DIALYSIS FILTER KDI CGH MEDICAL, INC. AN69 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other PB 2000 VENTILATOR| HOSPAL BM22 CVVHD DIALYSIS PUMP| IVAC INFUSIION PUMP