BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUME SET FOR UV FLASH

    MDR report key: 1984379 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01765
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    September 21, 2010
    Report Date
    September 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE CONNECTION ISSUE FOR THE BAG LINE SPIKE NOT ABLE TO CONNECT TO A SPIKE PORT WAS NOT CONFIRMED IN THE LAB. BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLE WITH NO ABNORMALITY OBSERVED. THE REPORTED ISSUE WAS NOT CONFIRMED AND THE CAUSE WAS UNDETERMINED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE. 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

    A NURSE REPORTED THAT THE BAG LINE SPIKE OF A YUME SET COULD NOT BE CONNECTED TO THE SPIKE PORT OF A SOLUTION BAG WHILE USING A CLEAN FLASH DEVICE. THIS CONNECTION ISSUE OCCURRED DURING SET-UP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YUME SET FOR UV FLASH SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1