BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 2133742 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07816
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    April 10, 2010
    Report Date
    April 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. 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. (B)(4). 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT. (B)(4).

    Description of Event or Problem · 1

    THIS IS A CASE THAT WAS REPORTED ON (B)(6) 2010 TO A BAXTER CUSTOMER SERVICE REPRESENTATIVE FROM (B)(6). IT WAS REPORTED THAT DURING THE INFUSION OF ACCUSOL 35 5000ML, IT WAS NOTICED THAT PRECIPITATION WAS IN THE LINE. THE HOSPITAL WAS UNSURE WHETHER THE PRECIPITATION HAD BEEN NOTED PRE OR POST DILUTION. ONE PATIENT WAS INVOLVED, HOWEVER NO INJURY OR MEDICAL INTERVENTION OCCURRED. THE SAMPLE IS NOT AVAILABLE 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 09K27G70

    Patients

    Seq Age Sex Outcome Treatment
    1