BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOFILTER

    MDR report key: 32206 · Received April 19, 1996

    Report

    Report Number
    1003770-1996-09004
    Event Type
    Injury
    Date Received
    April 19, 1996
    Date of Event
    April 9, 1996
    Report Date
    April 17, 1996
    Manufacturer
    ASAHI MEDICAL CO.
    Product Code
    FKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    DURING A TREATMENT ON A PT, THEY FAILED TO RINSE THE HEMOFILTER ACCORDING TO INSTRUCTIONS, AND AS A RESULT, THE PT'S BLOOD CAME IN CONTACT WITH GLYCERINE. DIURETICS AND BLOOD PRODUCTS WERE ADMINISTERED TO PT TO ALLEVIATE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOFILTER HEMOFILTER FKJ ASAHI MEDICAL CO. PAN 50 P UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention