BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1880576 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04832
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED 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. THE SAMPLE IS NOT AVAILABLE. A BATCH REVIEW WAS PERFORMED AND FOUND TO BE ACCEPTABLE. RETENTION SAMPLES WERE VISUALLY EVALUATED AND WERE FOUND TO BE ACCEPTABLE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    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 THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    THIS IS A REPORT OF AN INCIDENT THAT WAS OBSERVED BY BAXTER PERSONNEL DURING A VISIT TO THE (B)(6) HOSPITAL UNIT IN (B)(6). THE THERAPY SETTINGS WERE BLOOD FLOW 200ML/H, PREDILUTION 1500ML/H, POSTDILUTION 1500ML/H. SEVENTY SEVEN HOURS AFTER COMMENCING CVVH WHITE PRECIPITATION WAS OBSERVED IN PREDILUTION AND POSTDILUTION LINES. THE LINES WERE CHANGED BY THE HOSPITAL STAFF. NO FURTHER INFORMATION WAS PROVIDED.

    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 10B23G70

    Patients

    Seq Age Sex Outcome Treatment
    1 AQUARIUS DEVICE