BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 2133746 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07819
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    April 8, 2010
    Report Date
    April 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER WAS NOT KNOWN, THEREFORE NO BATCH REVIEW COULD BE PERFORMED. SAMPLES FOR SIMILAR COMPLAINTS HAVE BEEN ANALYZED. THE PRECIPITATES WERE ISOLATED AND INSPECTED USING VARIOUS LABORATORY ANALYTICAL METHODS. THE ANALYSES CONCLUDED THAT THE PRECIPITATES OBSERVED ARE CALCIUM CARBONATES. A (B)(6) 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)(6) 2008 WITH A PH ABOVE 7.3 AT FINAL ANALYSIS IS NOT RELEASED. A MORE LONG-TERM PREVENTATIVE PLAN IS CURRENTLY BEING EVALUATED BY THE TEAM TO PERMANENTLY ELIMINATE THIS PROBLEM. 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. 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)(6).

    Description of Event or Problem · 1

    THE COMPLAINT WAS RECEIVED FROM (B)(6) HOSP AND REFERS TO AN INCIDENT INVOLVING AN ACCUSOL 35. THE REPORTER STATED THAT DURING PATIENT USE, PRECIPITATION WAS SEEN IN THE PRE-DILUTION AND POST-DILUTION LINES. A SAMPLE WAS NOT AVAILABLE, AS THE CUSTOMER INADVERTENTLY DISCARDED IT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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

    Patients

    Seq Age Sex Outcome Treatment
    1