BEUDAMED
    FDA Adverse Event Death Summary report: N

    U1105 S1000 TINA HD WITH NIBP

    MDR report key: 1251668 · Received December 2, 2008

    Report

    Report Number
    1423500-2008-00961
    Event Type
    Death
    Date Received
    December 2, 2008
    Date of Event
    November 8, 2008
    Report Date
    November 10, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K910215
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON SITE VISIT WAS CONDUCTED BY THE FIELD SERVICE ENGINEER ON 11/10/2008. RESULTS OF EVALUATION INDICATE: ON INITIAL INSPECTION OF MACHINE NOTED THAT THE LIGHT EMITTING DIODE (LED) ON THE NUMBER ONE END OF STROKE (EOS) SENSOR WAS FLICKERING BEFORE COMING ON SOLID. THE EOS LENS WAS CLEANED AND THE LED CAME ON SOLID WITH NO FLICKER, OPERATING NORMALLY. NO PARTS CHANGED OR CALIBRATIONS DONE. THE DEVICE FUNCTIONED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PATIENT DEATH OCCURRED IN 2008 DURING PATIENT THERAPY ON THE TINA 1000 MACHINE. THE PATIENT WAS IN THE ICU RECEIVING HEMODIALYSIS, WHEN THE EVENT OCCURRED. REPORTEDLY, THERE WERE NO ALARMS OR ISSUES THAT OCCURRED WITH THE MACHINE. THE PATIENT WAS IN CRITICAL CONDITION. AN ON-SITE VISIT HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U1105 S1000 TINA HD WITH NIBP 78KDJ KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death