BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH TRANSFER SET

    MDR report key: 2201247 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10566
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED IN THE LAB FOR TUBING LEAKAGE DUE TO A CUT/HOLE IN THE TUBING (8.6 INCHES FROM THE BASE OF THE WHITE TWIST SLEEVE WHEN CLOSED, PER UNDERWATER PRESSURE TEST). EXACT ROOT CAUSE CANNOT BE CONFIRMED FOR THE CUT/SLICE/HOLE IN THE TUBING. ALTHOUGH THE LEAK WAS NOTICED DURING CLEAN FLASH USE, THE LOCATION IN THIS CASE MAKES THE CUT UNLIKELY TO HAVE COME FROM THIS DEVICE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED

    Description of Event or Problem · 1

    A DOCTOR REPORTED TO BAXTER (B)(4) THAT WHILE CHANGING THE BAGS A LEAK WAS NOTICED IN THE TUBING. THE SET HAD BEEN USED FOR 180 DAYS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1