BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3190527 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16448
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 3, 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). A SAMPLE WAS RECEIVED FOR EVALUATION BY BAXTER PRODUCT ANALYSIS LABORATORY. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED WITH NO ISSUES NOTED. THE ANALYSIS WAS UNABLE TO DUPLICATE THE LEAK DURING TESTING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES. THE DEVICE WAS HAND TIGHTENED TO A LAB TITANIUM ADAPTER WITH NO DIFFICULTY NOTED. UNDER-WATER PRESSURE TESTING AND DIMENSIONAL INSPECTION FOUND THE DEVICE TO BE WITHIN SPECIFICATIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2. THIS IS A REPORT OF A LEAK IN THE JUNCTION BETWEEN THE UV FLASH TRANSFER SETS AND THE LOCKING TITANIUM ADAPTER THAT OCCURRED WHILE THE PATIENT WAS PERFORMING PERITONEAL DIALYSIS (PD) THERAPY (DETAILS NOT PROVIDED). THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION INDICATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290913 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 LOCKING TITANIUM ADAPTER