BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0707 TINA SINGLE PUMP NIBPLCD

    MDR report key: 1844370 · Received September 24, 2010

    Report

    Report Number
    1423500-2010-03719
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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 DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF A FLUID LEAK WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE THAT THE WATER SUPPLY CONNECTOR WAS LEAKING. APPROPRIATE CORRECTIVE ACTION WAS TAKEN TO RESOLVE THE ISSUE BY PERFORMING ALL THE NECESSARY TESTS, CALIBRATIONS AND REPAIRS. THE CONNECTOR WAS REPLACED ON THE DEVICE TO FIX THE REPORTED CONDITION. THE DEVICE WAS TESTED AND PASSED ALL TESTING. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT IN WHICH A CUSTOMER STATED THE DEVICE HAD A WATER LEAK. THE FIELD SERVICE REPRESENTATIVE WENT ONSITE TO REPAIR THE DEVICE.

    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 - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1