BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 2133793 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07835
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    November 24, 2008
    Report Date
    November 24, 2008
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (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 REPORTED PROBLEM OF PRECIPITATE WAS CONFIRMED. FIVE SAMPLE VIALS WERE RETURNED. ONE VIAL APPEARS TO HAVE LEAKED. THE REMAINING FOUR VIALS CONTAINED BETWEEN 10-20 MLS OF SOLUTION. THE SOLUTION APPEARS TO BE CLEAR IN ALL VIALS. A SAMPLE OF TUBING WAS ALSO RETURNED. THIS TUBING SAMPLE CONTAINED PRECIPITATE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. 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. ANY ACCUSOL PRODUCT MANUFACTURED AFTER (B)(4) 2008 WITH (B)(4) AT FINAL ANALYSIS IS NOT RELEASED. A MORE LONG-TERM PREVENTATIVE PLAN IS CURRENTLY BEING EVALUATED BY THE TEAM TO PERMANENTLY ELIMINATE THIS PROBLEM.

    Description of Event or Problem · 1

    A NURSE CONTACTED BAXTER IRELAND TO REPORT AN EPISODE OF PRECIPITATE NOTED IN THE PRE AND POST DILUTION LINE AND DEGASSING CHAMBER 63 HOURS INTO PATIENT THERAPY. AS A RESULT TREATMENT WAS DISCONTINUED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 08I12G70

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR