BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2983287 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04939
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 7, 2012
    Report Date
    February 7, 2013
    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 IS A PRODUCT NOT DISTRIBUTED IN THE U.S. AND DOES NOT HAVE A 510K NUMBER. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THIS COMPLAINT FOR A REPORT OF A LEAK WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    DURING AN EVALUATION OF A TRANSFER SET THAT WAS RETURNED TO BAXTER, IT WAS FOUND TO HAVE A LEAK COMING FROM A CRACK AT THE BASE OF THE SPIKE. THE LEAK WAS FOUND DURING A VISUAL INSPECTION AND LEAK TESTING OF THE TRANSFER SET. AS THIS WAS FOUND DURING EVALUATION, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88581 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1