BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2922881 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01424
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 28, 2012
    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 PRODUCT IS NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER.THE ACTUAL SAMPLE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED AND ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE EVALUATION. VISUAL INSPECTION PERFORMED WITH THE FOLLOWING ISSUES NOTED: FLARED PATIENT ADAPTER AND DISCOLORED PATIENT ADAPTER. LEAK TESTING PERFORMED WITH NO ISSUES NOTED. CLEAR PASSAGE TEST PERFORMED WITH NO ISSUES NOTED. CLAMP FUNCTION TEST PERFORMED WITH NO ISSUES NOTED. SAMPLE WAS CONFIRMED FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A UV FLASH TRANSFER SET'S CONNECTOR SEPARATED FROM A TITANIUM ADAPTER. THERE WAS NO VISIBLE DAMAGE OR RESIDUE ON THE CONNECTOR. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27852 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTOR