BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL KO CLEARFLEX 5LCE MARKED

    MDR report key: 1932638 · Received December 19, 2010

    Report

    Report Number
    1423500-2010-07045
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 25, 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. A REVIEW OF THE BATCH FILE WAS FOUND TO BE ACCEPTABLE. A TREND REVIEW WAS COMPLETED AND THERE WAS NO SIGNIFICANT TREND FOR THIS ISSUE. ONE SAMPLE WAS RECEIVED AND THE COMPLAINT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT IS A RESULT OF A CUSTOMER CONTACTING BAXTER. THE CUSTOMER REPORTED THAT THE MEDICATION PORT DISLODGED ON AN ACCUSOL BAG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL KO CLEARFLEX 5LCE MARKED DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 09F08G70

    Patients

    Seq Age Sex Outcome Treatment
    1