BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1943239 · Received December 31, 2010

    Report

    Report Number
    1423500-2010-07471
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A BATCH REVIEW WAS 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 REVISED SPECIFICATION FOR SOLUTION PH HAS BEEN IMPLEMENTED (B)(4). THIS IS EFFECTIVE FROM AUGUST 2008. 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. (B)(4). WE MANUFACTURED A NUMBER OF ACCUSOL CODES USING THIS MATERIAL IN DECEMBER 2010. WE PLAN TO INTRODUCE THIS RAW MATERIAL FOR ALL ACCUSOL CODES OVER THE NEXT NUMBER OF MONTHS. BAXTER CONTINUES TO WORK ON THE SOLUTION FORMULATION TO OPTIMIZE ITS PERFORMANCE.

    Description of Event or Problem · 1

    THIS IS A CASE, WHICH WAS REPORTED TO BAXTER. THE COMPLAINT WAS RECEIVED AND REFERS TO AN INCIDENT INVOLVING AN ACCUSOL 35 5L BAG. THE REPORTER STATES THAT WHILE A PATIENT WAS RECEIVING THERAPY, PRECIPITATION WAS NOTICED IN THE DIALYSATE LINE BOTH PRE AND POST PUMP, A SET WAS IN USE 36HRS AND TREATMENT WAS DISCONTINUED. NO INJURY OR MEDICAL INTERVENTION HAS BEEN REPORTED. AN UPDATE WAS PROVIDED. NO ADVERSE EVENT OR INJURY OCCURRED AND NO MEDICATION WAS GIVEN THROUGH THE LINES.

    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 10I21G71

    Patients

    Seq Age Sex Outcome Treatment
    1 HEMODIALYSIS MACHINE