BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXELTRA 150 - SINGLE USEHIGH FLUX DIALYZER

    MDR report key: 1001131 · Received February 15, 2008

    Report

    Report Number
    1423500-2008-00092
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    November 6, 2007
    Report Date
    November 8, 2007
    Manufacturer
    NIPRO CORP. USD
    Product Code
    KDI
    PMA / PMN Number
    K030975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER IS MONITORING ISSUES LIKE THIS. SHOULD SIGNIFICANT INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE TINA MACHINE WAS CHECKED BY THE TECHNICAL SERVICE REPRESENTATIVE. THE INSTRUMENT SHOWS A FAIL IN BYPASS. IT IS TURNED OFF AND TURNED ON AGAIN BUT THE MACHINE STILL SHOWS THE FAIL. THE PT IS DISCONNECTED BY MANUAL PROCEDURE. THE PT COMPLAINED OF PAIN IN HIS CHEST, DROWN, HEADACHE, AND HE HAD A RAISE IN HIS ARTERIAL PRESSURE, HE REMAINS IN OBSERVATION AND IMPROVES IN A SPONTANEOUS WAY. THE FACILITY COMPARES THIS INCIDENT TO ANOTHER TIME WHEN THE FAILS SHOWED BY THE TINA MACHINE USING THE SAME MANUAL PROTOCOL AND THERE WAS NO PT SYMPTOMS USING ANOTHER DIALYZER DIFFERENT TO THE EXELTRA 150. THE PERSON IN CHARGED OF THE HOSPITAL DECLARES TODAY (2007) THAT THE PTS ARE STILL IN TREATMENT AND NO SYMPTOMS HAVE BEEN SHOWED AGAIN. THE REPORTER AT THE FACILITY ONLY RELATES THE INCIDENT WITH THE EXELTRA 150 DIALYZER. THE DIALYZER WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXELTRA 150 - SINGLE USEHIGH FLUX DIALYZER 78KDI KDI NIPRO CORP. USD 07F07A

    Patients

    Seq Age Sex Outcome Treatment
    1