BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 2143349 · Received June 29, 2011

    Report

    Report Number
    1423500-2011-08472
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 24, 2010
    Report Date
    July 10, 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. THE MDR AWARE DATE IS (B)(6) 2010 THE DATE BAXTER RECEIVED INFORMATION THAT AN ADVERSE EVENT OR MEDICAL DEVICE MALFUNCTION HAS OCCURRED. SAMPLE WAS DISCARDED BY CUSTOMER. A BATCH FILE REVIEW WAS COMPLETED AND WAS FOUND TO BE ACCEPTABLE. SAMPLES FOR SIMILAR COMPLAINTS HAVE BEEN ANALYSED. THE PRECIPITATES WERE ISOLATED AND INSPECTED USING VARIOUS LABORATORY ANALYTICAL METHODS. THE ANALYSES CONCLUDED THAT THE PRECIPITATES OBSERVED ARE CALCIUM CARBONATES. A (B)(4) TEAM HAS BEEN SET UP TO FURTHER INVESTIGATE THIS ISSUE. INVESTIGATIONS INTO THIS ISSUE BY THE TEAM HAVE PROGRESSED. THE PH OF THE SOLUTION HAS BEEN IDENTIFIED AS THE PRIMARY ROOT CAUSE OF THIS PROBLEM. (B)(4). A MORE LONG-TERM PREVENTATIVE PLAN IS CURRENTLY BEING EVALUATED BY THE TEAM TO PERMANENTLY ELIMINATE THIS PROBLEM.

    Description of Event or Problem · 1

    PRECIPITATION NOTED IN THE DIALYSATE AND REPLACEMENT LINES AFTER 48 HOURS ON HEMODIALYSIS THERAPY. KCL 15MMOL WAS PRESENT IN THE BAGS AT THE TIME. THE CUSTOMER HAS NOT RETURNED THE SAMPLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 08J02670

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS