BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0707 TINA SINGLE PUMP NIBPLCD

    MDR report key: 1832196 · Received September 13, 2010

    Report

    Report Number
    1423500-2010-03353
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 17, 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 DEVICE EVALUATION/ON SITE SERVICING HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF THE WATER LEAK OF THE UNIT WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE BROKEN TUBING. APPROPRIATE CORRECTIVE ACTION WAS TAKEN TO RESOLVE THE ISSUE BY PERFORMING ALL THE NECESSARY TESTS, CALIBRATIONS AND REPAIRS. THE TUBING WAS REPLACED TO FIX THE REPORTED CONDITION. THE DEVICE WAS TESTED AS PER BAXTER OPERATING PROCEDURES AND PROTOCOLS AND PASSED ALL TESTING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION WERE NOT PROVIDED. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(4) TO REPORT THAT A TINA SINGLE PUMP HEMODIALYSIS MACHINE HAD A WATER LEAK. IT IS UNKNOWN AT THIS TIME IF THE LEAK OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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