BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1871711 · Received October 15, 2010

    Report

    Report Number
    1423500-2010-04455
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 22, 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). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE BATCH FILE WAS FOUND TO BE ACCEPTABLE. RETENTION SAMPLES WERE VISUALLY EVALUATED AND FOUND TO BE ACCEPTABLE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. 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

    THE CUSTOMER REPORTED PRECIPITATION FORMATION WAS OBSERVED ON THE (B)(6) 2010. HAEMOFILTRATION WAS THE THERAPY THAT WAS PERFORMED. FOUR ACCUSOL 35 5000ML BAGS WERE USED ON THE MACHINE. THE BLOOD FLOW WAS 200ML/HR, PREDILUTION WAS 1200ML/HR, POSTDILUTION WAS 1200ML/HR AND THE TEMPERATURE WAS 37 DEGREES C. THE PATIENT WAS BEING TREATED FOR 48 HOURS BEFORE THE PRECIPITATION WAS NOTICED. THE CUSTOMER STATED 48 HOURS HAD ELAPSED BETWEEN THE LINES INVOLVED WERE SET ON THE MACHINE. THE PATIENT'S THERAPY WAS STOPPED AND BLOOD WAS RETURNED TO THE PATIENT. POTASSIUM (20MMOLS) WAS INJECTED INTO THE ACCUSOL BAGS. HEPARIN WAS ADDED THROUGH THE LINES. ALL FOUR ACCUSOL BAGS WERE MIXED. PRECIPITATION WAS PRESENT BETWEEN THE HEATING COILER AND THE DEGASSING CHAMBER, BETWEEN THE DEGASSING CHAMBER AND PREDILUTION PUMP, BETWEEN THE DEGASSING CHAMBER AND POSTDILUTION PUMP, AFTER PREDILUTION PUMP AND AFTER POSTDILUTION PUMP. THERE WAS NO ADVERSE EVENTS/CONSEQUENCES THAT OCCURRED DURING THIS PERIOD OF THE PRECIPITATION FORMATION.

    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 10E11G71

    Patients

    Seq Age Sex Outcome Treatment
    1 AQUAMAX HF12 FILTER, AQUARIUS HEMODIALYSIS DEVICE