BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2900078 · Received January 7, 2013

    Report

    Report Number
    1416980-2013-00409
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    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). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER H12E09030 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED.A EVALUATION OF THE COMPANION SAMPLE WAS CONDUCTED AND ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE EVALUATION. VISUAL INSPECTION PERFORMED WITH NO ISSUES NOTED. LEAK TESTING PERFORMED WITH NO ISSUES NOTED. CLEAR PASSAGE TEST PERFORMED WITH NO ISSUES NOTED. FUNCTIONALLY HAND TIGHTENED A LAB TITANIUM ADAPTER TO SET WITH DIFFICULTY NOTED. SAMPLE WAS CONFIRMED FOR THE REPORTED PROBLEM. NO ROOT CAUSE WAS DETERMINED.IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE SAMPLE HAS BEEN MADE. SHOULD THE SAMPLE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. 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 SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    BAXTER (B)(4) WAS CONTACTED ON (B)(4) 2012 AND THE PATIENT CONNECTOR WAS NOT CONNECTED WITH THE TITANIUM ADAPTER WELL WHEN THE CUSTOMER CHANGED THE TRANSFER SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7036 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H12E09030

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE