BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1943242 · Received December 31, 2010

    Report

    Report Number
    1423500-2010-07474
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 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). A REVIEW OF THE MANUFACTURING RECORDS WAS ACCEPTABLE. A REVIEW OF THE COMPLAINT FILE CONFIRMS THAT NO SIMILAR COMPLAINT WAS RECEIVED FOR THE BATCH. A PIECE OF THE PRE-DILUTION LINE TUBING WAS RETURNED IN A SAMPLE VIAL. THE TUBING CONTAINED WHITE PRECIPITATE. 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.

    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. THE PRODUCT SAMPLE HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A CASE, WHICH WAS REPORTED TO BAXTER FROM THE CUSTOMER AND REFERS TO AN INCIDENT INVOLVING AN ACCUSOL 35 5L BAG. THE REPORTER STATES THAT WHILE A PATIENT WAS RECEIVING HAEMODIAFILTRATION THERAPY ON AN AQUARIUS MACHINE USING THE ABOVE SOLUTION, DURING A CHECK ON THE PROGRESS OF THERAPY WHICH WAS 39 HRS AFTER COMMENCEMENT OF THERAPY, IT WAS NOTICED THAT THE DIALYSATE LINE WAS FULL OF AIR AND CRYSTALLIZED PARTICLES. THE PARTICLES WERE SMALL ALMOST LIKE BUBBLES IN ALL OF THE 4 BAGS THAT WERE ATTACHED TO THE MACHINE AND ALSO VISIBLE IN THE ENTIRE REPLACEMENT SOLUTION SIDE. NO PATIENT INJURY HAS BEEN REPORTED / CONFIRMED BY THE CUSTOMER.

    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 10I15G72

    Patients

    Seq Age Sex Outcome Treatment
    1 62 DA HEMODIALYSIS MACHINE