BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3023092 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07393
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS EVALUATED BY BAXTER. A VISUAL INSPECTION AND LEAK TESTING NOTED LEAK COMING FROM A CUT IN THE TUBING NEAR THE SLEEVE. CLEAR PASSAGE AND CLAMP FUNCTION TESTS WERE PERFORMED WITH NO ISSUES NOTED. THE SAMPLE EVALUATION CONFIRMED THE REPORTED PROBLEM. THE ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LEAK DURING PERITONEAL DIALYSIS (PD) THERAPY. THE CUSTOMER REPORTED THAT LEAKAGE FROM THE SILICONE TUBING OF THE TRANSFER SET WAS FOUND DURING USE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126061 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1