BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 1000 SPDS

    MDR report key: 757123 · Received November 10, 2005

    Report

    Report Number
    1423500-2005-01773
    Event Type
    Malfunction
    Date Received
    November 10, 2005
    Date of Event
    October 1, 2005
    Report Date
    October 20, 2005
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON OCTOBER 21, 2005 A BAXTER FIELD SERVICE ENGINEER WENT TO THE FACILITY TO EVALUATE THE INSTRUMENT. THE INSTRUMENT HAD POSITIVE ENDOTOXINS ABOVE 3. THE FIELD SERVICE ENGINEER REPLACED FILTERS INSIDE THE INSTRUMENT AND THE CONCENTRATE FILTERS, REPLACED THE DIAPHRAGMS, CHECK VALVES, AND THEN COMPLETED FUNCTIONAL CHECKS. THE INSTRUMENT WAS THEN BLEACHED AND HEAT CLEANED. THE FIELD SERVICE ENGINEER INSTRUCTED THE FACILITY TO DISINFECT THE INSTRUMENT EVERYDAY UNTIL THE ENDOTOXIN LEVELS ARE NEGATIVE.

    Description of Event or Problem · 1

    ON OCTOBER 20, 2005 THE FACILITY REPORTED THAT A SYSTEM 1000 INSTRUMENT HAD POSITIVE ENDOTOXINS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED IN ASSOCIATION TO THIS INCIDENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 1000 SPDS SYSTEM 1000 FII BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN