BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0707 TINA SINGLE PUMP NIBPLCD

    MDR report key: 1873277 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04590
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - MIAMI LAKES
    Product Code
    KDI
    PMA / PMN Number
    K970446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL TINA DEVICE WAS EVALUATED ON-SITE AT THE CUSTOMER FACILITY AND THE REPORTED CONDITION OF A WATER LEAK WAS CONFIRMED. THE ROOT CAUSE OF THE LEAK WAS DETERMINED TO BE A BROKEN INLET WATER CONNECTOR. APPROPRIATE CORRECTIVE ACTION WAS TAKEN TO RESOLVE THE ISSUE BY PERFORMING ALL THE NECESSARY TESTS, CALIBRATIONS AND REPAIRS. THE INLET WATER CONNECTOR WAS REPLACED ON THE DEVICE TO FIX THE REPORTED CONDITION. THE DEVICE WAS TESTED AS PER BAXTER OPERATING PROCEDURES AND PROTOCOLS AND PASSED ALL TESTING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO (B)(4) TECHNICAL SERVICES (CTS) AN ISSUE WITH ONE TINA HEMODIALYSIS MACHINE. THE CUSTOMER REPORTED THAT THE DEVICE HAD A WATER LEAK. THE BAXTER FIELD SERVICE REPRESENTATIVE ARRANGED TO GO ONSITE TO REPAIR THE DEVICE. AS SUCH, THE DEVICE WILL NOT BE RETURNED TO CTS FOR EVALUATION. AT THIS TIME, THE PROCESS STEP IS UNKNOWN AND THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U0707 TINA SINGLE PUMP NIBPLCD DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - MIAMI LAKES

    Patients

    Seq Age Sex Outcome Treatment
    1