BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN

    MDR report key: 1891832 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05325
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 3, 2010
    Report Date
    October 13, 2010
    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). THE CUSTOMER REPORT OF A DAMAGED SET WAS CONFIRMED DURING EVALUATION. THE SPIKE WAS COMPLETELY BROKEN OFF AT THE BASE. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SET BROKE AND LEAKAGE WAS FOUND FROM THE CONNECTION BETWEEN THE SPIKE OF THE SET AND THE SPIKE PORT OF THE UV TWIN BAG DURING THE DRAINAGE. THE PATIENT CONNECTED THE SET TO THE UV DISCONNECT CAP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE ACTUAL SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1