BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1884334 · Received October 27, 2010

    Report

    Report Number
    1423500-2010-04987
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 26, 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 REVIEW OF THE BATCH FILE WAS FOUND TO BE ACCEPTABLE. A TREND REVIEW WAS COMPLETED AND THERE WAS NO SIGNIFICANT TREND. RETENTION SAMPLES WERE VISUALLY EVALUATED AND FOUND TO BE ACCEPTABLE. ANALYSIS OF SAMPLES FOR PREVIOUS COMPLAINTS FOR THIS ISSUE CONFIRMS THAT THE PRECIPITATES CONSIST OF CALCIUM CARBONATES. 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.

    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. PER THE CUSTOMER, THE SAMPLE WAS DISCARDED.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PATIENT COMMENCED HAEMOFILTRATION WITH ACCUSOL 35. THE MACHINE USED WAS AN AQUARIUS MACHINE, WHICH WAS SET TO AUTOMATIC DEGASSING. THE THERAPY SETTINGS WERE BLOOD FLOW 200ML/H, PREDILUTION 1100ML/H, POSTDILUTION 3000ML/H AND THE TEMPERATURE WAS 38 DEGREES CELSIUS. POTASSIUM CHLORIDE 20MMOL 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 MACHINE. ON (B)(6) 2010, 62 HOURS AFTER COMMENCING TREATMENT (AND THE LINES BEING SET ON THE MACHINE, PRECIPITATION WAS OBSERVED AFTER PREDILUTION PUMP AND AFTER POSTDILUTION PUMP. AN ALARM FOR BALANCE CHECK DIALYSATE / EFFLUENT LINES WAS NOTICED BEFORE THE PRECIPITATION WAS OBSERVED. AFTER THE PRECIPITATION WAS NOTICED THE TREATMENT WAS DISCONTINUED. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY WAS REPORTED.

    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 09K26G70

    Patients

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