BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1875179 · Received October 19, 2010

    Report

    Report Number
    1423500-2010-04628
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    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 THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. A BATCH REVIEW WAS PERFORMED AND 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).

    Description of Event or Problem · 1

    THIS IS ONE OF TWO REPORTS THAT WAS RECEIVED FROM A NURSE ON (B)(6) 2010. THE PATIENT COMMENCED HAEMOFILTRATION WITH ACCUSOL 35. THE THERAPY SETTINGS WERE BLOOD FLOW 200ML/H, PREDILUTION 700ML/H, POSTDILUTION 2800ML/H AND THE TEMPERATURE WAS 37 DEGREES C. POTASSIUM CHLORIDE (KCL) 20MMOL DOSE WAS ADDED TO THE ACCUSOL BAGS BUT NO MEDICATION WAS ADDED THROUGH THE LINES. ALL 4 BAGS OF ACCUSOL WERE MIXED AND WERE CONNECTED TO THE CONTINUOUS RENAL REPLACEMENT THERAPY MACHINE. ON (B)(6) 2010, 52 HOURS AFTER COMMENCING HAEMOFILTRATION AND THE LINES BEING SET ON THE MACHINE, PRECIPITATION WAS OBSERVED IN THE HEATING COILER, BETWEEN THE HEATING COILER AND DEGASSING CHAMBER, IN THE DEGASSING CHAMBER, BETWEEN DEGASSING CHAMBER AND PREDILUTION PUMP, BETWEEN DEGASSING CHAMBER AND POSTDILUTION PUMP AND AFTER PREDILUTION PUMP. A BALANCE ALARM (B)(4) WAS NOTICED BEFORE THE PRECIPITATION WAS OBSERVED. AFTER THE PRECIPITATION WAS NOTICED THE TREATMENT WAS DISCONTINUED. NO ADVERSE EVENT WAS REPORTED. 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 10A24G71

    Patients

    Seq Age Sex Outcome Treatment
    1 AQUARIUS DEVICE, AQUALINE LINES, AQUAMAX FILTER