BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL K+4 CLEARFLEX 5L (CE MARK)

    MDR report key: 1911199 · Received November 30, 2010

    Report

    Report Number
    1423500-2010-06390
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 5, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. EVALUATION OF THE DEVICE HAS BEGUN; HOWEVER, HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE EVALUATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED AND THE REPORT CONFIRMED. A REVIEW OF THE BATCH FILE WAS FOUND TO BE ACCEPTABLE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS REPORT IS THE RESULT OF A CUSTOMER CONTACTING BAXTER. THE CUSTOMER REPORTED THE PRODUCT WAS LEAKING AND THAT THE HOLE WAS IN THE SIDE SEAM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL K+4 CLEARFLEX 5L (CE MARK) DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 08J10G70

    Patients

    Seq Age Sex Outcome Treatment
    1