BEUDAMED
    FDA Adverse Event Death Summary report: N

    A-18

    MDR report key: 371171 · Received January 4, 2002

    Report

    Report Number
    1423500-2002-00008
    Event Type
    Death
    Date Received
    January 4, 2002
    Date of Event
    March 16, 2001
    Report Date
    December 5, 2001
    Manufacturer
    ALTHIN MEDICAL, AN AFFILIATE OF BHC
    Product Code
    FJI
    Removal / Correction Number
    1423500-10/16/01-002R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    BAXTER NOTIFIED OF INCIDENT THROUGH THIRD PARTY LEGAL NOTIFICATION. PATIENT WAS UNDERGOING DIALYSIS AT THE CLINIC DURING THE TIME PERIOD OF 3 MONTHS IN 2001. ACCORDING TO THE INFORMATION OBTAINED THE PATIENT HAD SURGERY DURING THE FIRST MONTH OF THE 3 MONTH PERIOD AND WAS DIAGNOSED WITH RENAL FAILURE AT THAT TIME. THE PATIENT BEGAN DIALYSIS TREATMENT WITH NO COMPLICATION AND SUDDENLY DIED IN THE THIRD MONTH. BAXTER RECORDS SHOW THAT THE CLINIC WAS USING ALTHANE DIALYZERS AT THIS TIME. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A-18 HOLLOW FIBER DIALYZER FJI ALTHIN MEDICAL, AN AFFILIATE OF BHC A-18 NA04

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death