BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL 35 5L ACCUMOON(CZ/POL/SK/UK/IRL)

    MDR report key: 1905587 · Received November 23, 2010

    Report

    Report Number
    1423500-2010-06113
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 31, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SENT. 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. THE BATCH FILE WAS REVIEWED AND FOUND TO BE ACCEPTABLE. THE COMPLAINT FILE WAS REVIEWED AND NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THIS BATCH. A TREND REVIEW WAS COMPLETED AND THERE IS NO SIGNIFICANT TREND FOR THIS ISSUE. THERE WAS NO SAMPLE AVAILABLE FOR ANALYSIS. WE PERFORM FUNCTIONAL CHECKS ON A REPRESENTATIVE SAMPLE FROM EVERY BATCH AT PACKING. THIS CHECK INCLUDES THE EASE OF REMOVAL OF THE POUCH USING THE STARTER SLITS. WE HAVE NEVER EXPERIENCED ANY ISSUES WITH THIS PARTICULAR CHECK. WE CONTINUE TO CLOSELY MONITOR OUR COMPLAINTS FOR PROBLEMS OF THIS NATURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBSERVING ACCUSOL PRECIPITATION AFTER THE PREDILUTION PUMP WHICH OCCURRED ON (B)(6) 2010, 36 HOURS AFTER COMMENCING HEMODIALYSIS THERAPY. ACCUSOL WAS USED ON CONJUNCTION WITH AN AQUARIUS MACHINE, AQUALINE BLOOD LINE AND AQUAMAX FILTER. THE THERAPY SETTINGS WERE BLOOD FLOW 200ML/HR, PREDILUTION 1000ML/HR, POSTDILUTION 2000ML/HR AND THE TEMPERATURE WAS 39 DEGREES C. POTASSIUM CHLORIDE (KCL) 20MMOL WAS ADDED TO THE ACCUSOL BAGS BUT NO MEDICATION WAS ADDED THROUGH THE LINES. ALL BAGS OF ACCUSOL WERE MIXED. NO SPECIFIC ALARM WAS NOTICED BEFORE THE EVENT. AFTER IDENTIFICATION OF THE PRECIPITATION THE TREATMENT WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL 35 5L ACCUMOON(CZ/POL/SK/UK/IRL) DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 10I06G71

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR