BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0707 TINA SINGLE PUMP NIBPLCD

    MDR report key: 1840442 · Received September 21, 2010

    Report

    Report Number
    1423500-2010-03594
    Event Type
    Malfunction
    Date Received
    September 21, 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 TINA HEMODIALYSIS MACHINE INVOLVED IN THE EVENT WAS EVALUATED AT THE FACILITY AND THE REPORTED CONDITION OF THE DEVICE LEAKING WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE THAT THE BLOOD LEAK CHAMBER COVER WAS CRACKED. APPROPRIATE CORRECTIVE ACTION WAS TAKEN TO RESOLVE THE ISSUE BY PERFORMING ALL THE NECESSARY TESTS, CALIBRATIONS AND REPAIRS. THE BLOOD LEAK DETECTOR CHAMBER COVER 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, (B)(4) TECHNICAL SERVICES (CTS) RECEIVED A TELEPHONE CALL IN WHICH A CUSTOMER REPORTED AN ISSUE WITH ONE TINA HEMODIALYSIS MACHINE. THE CUSTOMER REPORTED THAT THE DEVICE HAD A WATER LEAK. THE BAXTER TECHNICIAN NOTIFIED THE FIELD SERVICE REPRESENTATIVE TO GO ONSITE TO REPAIR THE DEVICE. AS SUCH, THE DEVICE WILL NOT BE RETURNED TO CTS FOR EVALUATION. THE PROCESS STEP AND ANY REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ARE UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN INDICATED THAT THIS EVENT OCCURRED DURING RINSE MODE; THEREFORE, THERE WAS NO PATIENT CONNECTED, AND NO PATIENT INJURY. NO FURTHER INFORMATION IS AVAILABLE.

    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