BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL 35 5000ML (DRUG) (UK,IRELAND,POLAND,CZECH REP.,SLOV

    MDR report key: 1871290 · Received October 15, 2010

    Report

    Report Number
    1423500-2010-04439
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RETURNED AND EVALUATED. THE COMPLAINT WAS CONFIRMED. NO CONCLUSIONS CAN BE DRAWN FROM THE EVALUATION. BATCH REVIEW WAS PERFORMED AND FOUND ACCEPTABLE. TREND REVIEW COMPLETED- NO SIGNIFICANT TREND.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION. 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 THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE THE DEVICE FAILED THE GROUND BOND TEST INDICATING A HIGH RESISTANCE VALUE BETWEEN THE HC AND THE GROUND BOND ON THE POWER SUPPLY.

    Description of Event or Problem · 1

    THIS IS A CASE THAT WAS REPORTED ON THE (B)(6) 2010 TO A BAXTER BUSINESS REPRESENTATIVE FROM CORK UNIVERSITY HOSPITAL. IT WAS REPORTED THAT THE WING MECHANISM WAS PARTIALLY DISCONNECTED FROM THE SOLUTION BAG. FOUR UNITS WERE AFFECTED AND FOUR SAMPLES WERE RETURNED. NO PATIENT WAS INVOLVED. THIS REPORT IS ONE OF FOUR THAT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL 35 5000ML (DRUG) (UK,IRELAND,POLAND,CZECH REP.,SLOV DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 10F28G71

    Patients

    Seq Age Sex Outcome Treatment
    1