BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL 35POTASSIUM 4MMOL 5000ML(DRUG)(SWEDEN,NORWAY,DENMARK

    MDR report key: 1932441 · Received December 17, 2010

    Report

    Report Number
    1423500-2010-07014
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 20, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH REVIEW COMPLETED AND WAS ACCEPTABLE. A TREND REVIEW WAS COMPLETED AND THERE WAS NO SIGNIFICANT TREND. ANALYSIS OF SAMPLES FOR PREVIOUS COMPLAINTS FOR THIS ISSUE CONFIRMS THAT THE PRECIPITATES CONSIST OF CALCIUM CARBONATES. BAXTER HAS FOCUSED ON TIGHTER CONTROL OF THE SOLUTION MANUFACTURING PROCESS AND REDUCING MANUFACTURING VARIABILITY. A CAUTION IN USE NOTIFICATION WAS ISSUED TO CUSTOMERS AND HOSPITALS OUTLINING APPROPRIATE ACTIONS TO TAKE WHEN PRECIPITATES ARE IDENTIFIED. ALSO, THE DIRECTION INSERT FOR THE PRODUCT HAS BEEN UPDATED TO PROVIDE ADDITIONAL USER INSTRUCTIONS. BAXTER CONTINUES TO WORK ON THE SOLUTION FORMULATION TO OPTIMIZE ITS PERFORMANCE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW COMPLETED AND WAS ACCEPTABLE. ANALYSIS OF SAMPLES FOR PREVIOUS COMPLAINTS FOR THIS ISSUE CONFIRMS THAT THE PRECIPITATES CONSIST OF CALCIUM CARBONATES. BAXTER HAS FOCUSED ON TIGHTER CONTROL OF THE SOLUTION MANUFACTURING PROCESS AND REDUCING MANUFACTURING VARIABILITY. A REVISED SPECIFICATION FOR SOLUTION PH HAS BEEN IMPLEMENTED AND ONLY BATCHES THAT MEET A REVISED PH LIMIT OF 7.3 ARE RELEASED.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER. THE CUSTOMER REPORTED THAT THE ACCUSOL BAGS DEVELOPED A MILK WHITE PRECIPITATION. THE PRECIPITATION WAS NOTICED AFTER THE PRE AND POST DILUTION PUMPS. THE TIME THE PATIENT WAS ON THE TREATMENT BEFORE THE EVENT WAS NOTICED NOT CLEARLY IDENTIFIED. AFTER THE PRECIPITATION WAS NOTICED, THERAPY WAS STOPPED AND NEW TUBING AND SOLUTIONS WERE SET UP AND THERAPY WAS RESTARTED. NO MEDICATION WAS INJECTED INTO THE ACCUSOL BAGS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL 35POTASSIUM 4MMOL 5000ML(DRUG)(SWEDEN,NORWAY,DENMARK DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 10C12G71

    Patients

    Seq Age Sex Outcome Treatment
    1 70 DA