BEUDAMED
    FDA Adverse Event Death Summary report: N

    AF-180

    MDR report key: 448258 · Received March 12, 2003

    Report

    Report Number
    1423500-2003-00207
    Event Type
    Death
    Date Received
    March 12, 2003
    Date of Event
    February 1, 2003
    Report Date
    February 12, 2003
    Manufacturer
    ALTHIN MEDICAL, AN AFFILIATE OF BHC
    Product Code
    KDI
    Removal / Correction Number
    1423500-10/16/01-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEATH OF PATIENT "AFTER RECEIVING DIALYSIS TREATMENT ON A DIALYZER CONTAINING A BAXTER FILTER." NO ADDITIONAL INCIDENT DETAIL IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AF-180 HOLLOW FIBER DIALYZER KDI ALTHIN MEDICAL, AN AFFILIATE OF BHC AF-180 NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death