BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2964048 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03963
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 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). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED BY BAXTER. A VISUAL INSPECTION AND A LEAK TEST NOTED A CUT IN THE TUBING. A CLEAR PASSAGE TEST AND CLAMP FUNCTION TEST WERE PERFORMED WITH NO ISSUES NOTED. THE SAMPLE CONFIRMED THE REPORTED PROBLEM OF A LEAK. THE ROOT CAUSE OF THE CUT IN THE TUBING COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A LEAK WAS IDENTIFIED COMING FROM THE SILICONE TUBING OF A TRANSFER SET DURING USE. THE TRANSFER SET HAD BEEN IN USE FOR 180 DAYS. THE PATIENT PERFORMS CONTINUOUS AMBULATORY PERITONEAL DIALYSIS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67240 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1