BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPAL FLAT PLATE DIALYZER

    MDR report key: 18701 · Received October 4, 1994

    Report

    Report Number
    18701
    Event Type
    Malfunction
    Date Received
    October 4, 1994
    Date of Event
    May 7, 1994
    Report Date
    October 4, 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 AT 0900 FROM FILTER HEADER. SYSTEM CHANGED WITH LOSS OF PRIMING BLOOD, TRANSFUSION OF 1 UNIT PACKED RED CELLS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other