BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 2143303 · Received June 29, 2011

    Report

    Report Number
    1423500-2011-08470
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 8, 2010
    Report Date
    June 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 NOT RECEIVED. SAMPLES FOR SIMILAR COMPLAINTS WERE ANALYSED. THE PRECIPITATES WERE ISOLATED AND INSPECTED USING VARIOUS LABORATORY ANALYTICAL METHODS. THE ANALYSES CONCLUDED THAT THE PRECIPITATES OBSERVED ARE CALCIUM CARBONATES. A EUROPEAN TEAM, INCLUDING MEMBERS OF THE (B)(6) QA MANAGEMENT GROUP AND THE PRODUCT DEVELOPMENT GROUP IN (B)(6), HAS BEEN SET UP TO INVESTIGATE THIS ISSUE. THE RELEVANT MINISTRIES OF HEALTH HAVE BEEN NOTIFIED OF THIS PROBLEM. A CAUTION IN-USE NOTIFICATION LETTER HAS BEEN ISSUED, WHICH HAS BEEN PLACED ON ALL ACCUSOL PRODUCT BY THE RELEVANT CENTRES/HOSPITALS. 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. ANY ACCUSOL PRODUCT MANUFACTURED AFTER (B)(6) 2008 WITH A PH ABOVE 7.3 AT FINAL ANALYSIS IS NOT RELEASED. WE ARE CONFIDENT THAT THESE CORRECTIVE MEASURES WILL SIGNIFICANTLY REDUCE THE OCCURRENCE OF THIS PROBLEM. A MORE LONG-TERM PREVENTATIVE PLAN IS CURRENTLY BEING EVALUATED BY THE TEAM TO PERMANENTLY ELIMINATE THIS PROBLEM. A BATCH FILE REVIEW WAS COMPLETED AND WAS FOUND TO BE ACCEPTABLE. THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT. THIS REPORT IS BEING FILED LATE TO FULFILL BAXTER'S COMMITMENT TO PERFORM A TWO YEAR RETROSPECTIVE REVIEW OF RENAL COMPLAINTS IN RESPONSE TO FDA-WARNING LETTER (B)(4).

    Description of Event or Problem · 1

    THIS REPORT TO BAXTER (B)(4) ON (B)(6) 2010 WAS RECEIVED FROM (B)(6) HOSPITAL AND INVOLVES AN ACCUSOL 35 5000ML. THE BAG WAS CONNECTED TO A PATIENT, AND THE ACCUSOL FORMED CRYSTALS CAUSING THE TUBING TO BE BLOCKED. THE NURSE HAD NOT NOTICED CRYSTALS BEFORE IT WAS CONNECTED TO THE PATIENT. A SAMPLE HAS NOT BEEN MADE AVAILABLE. NO PATIENT INJURY HAS BEEN REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 10A26G71

    Patients

    Seq Age Sex Outcome Treatment
    1