BEUDAMED
    FDA Adverse Event Death Summary report: N

    AF-220

    MDR report key: 371199 · Received January 4, 2002

    Report

    Report Number
    1423500-2002-00007
    Event Type
    Death
    Date Received
    January 4, 2002
    Date of Event
    July 16, 2001
    Report Date
    December 13, 2001
    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 Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS ONE INCIDENT OF A PATIENT DEATH DURING PATIENT TREATMENT. PATIENT WAS FOUND UNRESPONSIVE 1 HOUR AND 15 MINUTES INTO THE PATIENT'S DIALYSIS TREATMENT. PATIENT WAS IMMEDIATELY ATTENDED TO BY EMERGENCY ROOM PERSONNEL, DEFIBRILLATED AND INTUBATED. RESUSCITATION WAS UNSUCCESSFUL.

    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 40 YR Death