BEUDAMED
    FDA Adverse Event Death Summary report: N

    AF-220

    MDR report key: 374985 · Received January 29, 2002

    Report

    Report Number
    1423500-2002-00113
    Event Type
    Death
    Date Received
    January 29, 2002
    Date of Event
    January 19, 2001
    Report Date
    January 3, 2002
    Manufacturer
    ALTHIN MEDICAL, AN AFFILIATE OF BHC
    Product Code
    KDI
    Removal / Correction Number
    1423500-10/16/01-002R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BAXTER LEGAL RECEIVED A TELEPHONE CALL FROM THE PATIENT'S FAMILY MEMBER INQUIRING ABOUT THE "FAULTY CATHETER CLASS ACTION". PATIENT'S FAMILY MEMBER INDICATED THAT THE PATIENT HAD BEEN ON DIALYSIS AND HAD EXPIRED IN 2001. REVIEW OF THE CENTER'S USE HISTORY INDICATES THIS CENTER EXCLUSIVELY USED THE AF 220 DIALYZERS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AF-220 HOLLOW FIBER DIALYZER KDI ALTHIN MEDICAL, AN AFFILIATE OF BHC AF-220 NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death