BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3222864 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18127
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND AN EVALUATION IS ANTICIPATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION, LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE OUTSIDE DIAMETER OF THE UV SPIKE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THE REPORTED PROBLEM COULD NOT BE CONFIRMED AND THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAK FROM THE JUNCTION BETWEEN THE TRANSFER SET AND A EXTRANEAL UV TWIN-BAG DURING THE DRAIN. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321378 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTRANEAL SOLUTION