BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 2133750 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07820
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    April 16, 2010
    Report Date
    April 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER REPORTED WAS NOT A VALID NUMBER; THEREFORE NO BATCH REVIEW COULD BE PERFORMED. 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 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 BY A CUSTOMER TO BAXTER (B)(4) AND REFERS TO AN INCIDENT INVOLVING AN ACCUSOL 35 5L. THE REPORTER STATED THAT WHILE THE PATIENT WAS CONNECTED AND RECEIVING TREATMENT, PRECIPITATION (CLOUDINESS ONLY) WAS NOTICED IN THE PRE DILUTION LINE AND HEATER COIL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED BY THE CUSTOMER. NO ALARMS WERE NOTED PRIOR TO THE EVENT. NO MEDICATION WAS INJECTED INTO THE ACCUSOL BAGS AND NO MEDICATION WAS ADDED THROUGH THE LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 09B16932A

    Patients

    Seq Age Sex Outcome Treatment
    1 AQUARUIS MACHINE