BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCURA HEMOFILTRATION SYSTEM

    MDR report key: 984576 · Received January 11, 2008

    Report

    Report Number
    1423500-2008-00018
    Event Type
    Death
    Date Received
    January 11, 2008
    Date of Event
    September 1, 2007
    Report Date
    December 12, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FIR
    PMA / PMN Number
    K974652
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE INSTRUMENT AT THE CUSTOMER LOCATION. DURING A VISUAL INSPECTION AND DRIED BLOOD WAS NOTED AROUND THE HEPARIN PUMP. THE HEPARIN PUMP WAS FOUND STUCK IN UP POSITION AND THE PRESSURE TRANSDUCER WAS DAMAGED. DURING A FUNCTIONAL INSPECTION, THE INSTRUMENT FAILED TRANS-MEMBRANE PRESSURE (TMP) SENSOR TEST IN SELF-TEST MODE. THE FSR FIXED THE HEPARIN PUMP, REPLACED THE PRESSURE TRANSDUCER AND PERFORMED FUNCTIONAL EVALUATION PER THE INSTRUMENT VERIFICATION DATA SHEET. THE INSTRUMENT PERFORMED ALL THE TESTS WITHIN SPECIFICATION ACCORDING TO THE MANUFACTURING RECOMMENDATION AND IT WAS RELEASED FOR PATIENT USE. BAXTER IS MONITORING ISSUES LIKE THIS. AN INVESTIGATION STILL PENDING. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PATIENT'S DEATH OCCURRED DURING USE OF THE INSTRUMENT. PER THE CLINICAL DIRECTOR, THE PATIENT WAS A PHYSICIAN IN VERY CRITICAL CONDITION AND HAD POOR PROGNOSIS. REPORTEDLY THIS PATIENT WAS DIALYZED ON THIS INSTRUMENT FOR A WHILE AND "THE ACCURA EXTENDED THE LIFE OF THE PATIENT AND THE PATIENT WAS GOING TO DIE". HOWEVER, DURING THE EVENT TREATMENT THERE WAS A PROBLEM WITH THE INSTRUMENT (DETAILS WERE NOT PROVIDED). REPORTEDLY, THE PATIENT'S DEATH OCCURRED "AROUND THE LABOR DAY" (NO EXACT DATE WAS PROVIDED). CURRENTLY THE CUSTOMER CONTACTED BAXTER TO REQUEST AN EVALUATION OF THE DEVICE. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURA HEMOFILTRATION SYSTEM 78FIR FIR BAXTER HEALTHCARE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death| H| L