BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN

    MDR report key: 1813481 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02852
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 31, 2010
    Report Date
    August 5, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET RECEIVED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP E MDR. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED IN THE LAB FOR TUBING LEAKAGE DUE TO A CUT/HOLE IN THE TUBING (1 1/2 INCHES FROM THE BASE OF THE WHITE TWIST SLEEVE WHEN CLOSED). EXACT ROOT CAUSE CANNOT BE CONFIRMED FOR THE CUT/SLICE/HOLE IN THE TUBING, HOWEVER, SOME POTENTIAL ROOT CAUSES ARE THE FOLLOWING: PATIENT FOLDING THE TUBE IN THE SAME LOCATION MULTIPLE TIMES. PATIENT MAY INCIDENTALLY CAUSE TUBING DAMAGE BY CONTACTING SHARP OBJECTS (ZIPPER, BUCKLE, OR A BED FENCE). MECHANICAL ASSIST TOOLS SUCH AS A HEMOSTAT CREATES CUTS IN THE TUBING WHEN CLAMPED. PATIENT'S METHOD OF PLACING THE SETS INTO THE UV GERMICIDAL EXCHANGE DEVICE (UV CLEAN FLASH ) INCORRECTLY. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT A LEAK IN THE TUBING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE ACTUAL SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1