BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 2143276 · Received June 28, 2011

    Report

    Report Number
    1423500-2011-08461
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 9, 2008
    Report Date
    June 13, 2008
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWO COMPANION SAMPLES FROM BATCH (B)(4) WERE RECEIVED. THE UNITS HAD NOT BEEN USED. THE OVERPOUCH HAD BEEN REMOVED FROM ONE OF THE SAMPLES. THE SOLUTION IN EACH OF THE SOLUTION BAGS WAS CLEAR. VARIOUS SAMPLES FOR SIMILAR COMPLAINTS HAVE BEEN SENT TO AND ANALYSED BY OUR SISTER PLANT IN (B)(4). THESE SAMPLES CONSISTED OF CLOUDY SOLUTION AND PRECIPITATES AND WERE TAKEN FROM THE PRE/POST DILUTION LINES. THE PRECIPITATES WERE ISOLATED AND INSPECTED USING VARIOUS LABORATORY ANALYTICAL METHODS. THE ANALYSES CONCLUDED THAT THE PRECIPITATES OBSERVED ARE CALCIUM CARBONATES. A EUROPEAN TEAM, INCLUDING MEMBERS OF THE (B)(4) QA MANAGEMENT GROUP AND THE PRODUCT DEVELOPMENT GROUP IN (B)(4), HAS BEEN SET UP TO INVESTIGATE THIS ISSUE. INVESTIGATIONS INTO THIS ISSUE ARE ONGOING. 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. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. 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. THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT. THIS REPORT IS BEING FILED LATE TO FULFILL BAXTER?S COMMITMENT TO PERFORM A TWO YEAR RETROSPECTIVE REVIEW OF RENAL COMPLAINTS IN RESPONSE TO (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT FROM A CUSTOMER FROM (B)(4) OF THE OBSERVANCE OF A CLOUDY PREDILUTION LINE WHILE PERFORMING CONTINUOUS VENO-VENOUS HEMODIALYSIS ON A PATIENT. IT WAS ALSO OBSERVED THAT PRECIPITATE HAD FORMED IN THE PREDILUTION LINE AND WHITENING OF THE POST DILUTION COULD ALSO BE OBSERVED. THERE WAS ONE (1) BAG OF ACCUSOL HANGING AT A TIME AND ALL BAGS HAD BEEN MIXED,. 20 MMOLS OF POTASSIUM CHLORIDE(KCL) WAS ADDED TO THE BAGS. THE TREATMENT WAS STOPPED. THERE WAS NO PATIENT/USER/OTHER PERSON?S INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 08B06G70

    Patients

    Seq Age Sex Outcome Treatment
    1