BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 2133759 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07825
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 15, 2010
    Report Date
    May 17, 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). A SAMPLE WAS RETURNED FOR EVALUATION WHICH CONSISTED OF FOUR SAMPLE VIALS. THESE SAMPLE VIALS WERE VISUALLY INSPECTED AND THE REPORTED PROBLEM WAS CONFIRMED. VIAL 1: MARKED AS SOLUTION FROM THE ACCUSOL BAG. SOLUTION APPEARED TO BE CLEAR. VIAL 2: MARKED AS SOLUTION FROM THE PRE-DILUTION LINE. SOLUTION APPEARED TO BE CLEAR. VIAL 3: MARKED AS SOLUTION FROM THE PRE-DILUTION LINE. SOLUTION WAS COLOURED, MAY HAVE BEEN IN CONTACT WITH THE PATIENT'S BLOOD. VIAL 4: CONTAINED A SECTION OF TUBING FROM THE PRE-DILUTION LINE. IT APPEARED TO CONTAIN PRECIPITATE ON THE INSIDE OF THE TUBING WALL. 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. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. 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. (B)(4).

    Description of Event or Problem · 1

    THIS IS A CASE, WHICH WAS REPORTED TO BAXTER (B)(4) ON (B)(6) 2010. THE COMPLAINT WAS RECEIVED FROM (B)(6) AND REFERS TO AN INCIDENT INVOLVING AN ACCUSOL 35 5000ML. THE REPORTER STATED THAT THE BAXTER ACCOUNT MANAGER OBSERVED THAT THE AQUALINE, FILTER AND ACCUSOL BAGS WERE KEPT ON THE AQUARIUS MACHINE (B)(4) TO BE OBSERVED. THE PATIENT THERAPY STARTED ON AN AQUARIUS MACHINE ON (B)(6) 2010. ON (B)(6) 2010 THE NURSE LOOKING AFTER THE PATIENT OBSERVED CLOUDY FLUID IN THE PREDILUTION LINE. AT THIS POINT THE ON CALL PHARMACIST WAS INFORMED AND THE TREATMENT WAS STOPPED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS NOTED. THE ACCOUNT MANAGER HAS TAKEN 3 SAMPLES FROM THE ACCUSOL FLUID THAT WAS USED IN THE AQUALINE AND THEY HAVE BEEN RETURNED TO BAXTER FOR EVALUATION; FROM THE ACCUSOL BAG, FROM THE DEGASSING CHAMBER, FROM THE PREDILUTION LINE & ALSO CUT OUT THE PPREDILUTION LINE SEGMENT. THE SOLUTION IN THE STERILE CONTAINER FROM THE PREDILUTION LINE HAD BEEN IN CONTACT WITH THE PATIENT'S BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 09I25G70

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR