BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1920449 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06791
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 15, 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. 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.

    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 FOR THIS ISSUE. ONE SAMPLE WAS RECEIVED AND THE COMPLAINT CONFIRMED. THE PROBLEM WAS PRODUCTION RELATED. THIS ISSUE WAS REVIEWED WITH THE TECHNICAL, QUALITY AND PRODUCTION TEAM RESPONSIBLE FOR THIS PRODUCT LINE. ADDITIONAL CHECKS WERE INTRODUCED TO ENSURE THAT THE MEDICATION IS PROPERLY SECURED TO THE SOLUTION BAG. WE HAVE DISCUSSED THIS PARTICULAR COMPLAINT WITH PRODUCTION/ENGINEERING AND WE HAVE OPENED A NON-CONFORMANCE INVESTIGATION REPORT TO INVESTIGATE THE TYPE OF ISSUE AND TO TRACK THE CORRECTIVE CORRECTIONS.

    Description of Event or Problem · 1

    THIS IS A CASE, WHICH WAS REPORTED TO BAXTER. THE COMPLAINT REFERS TO AN INCIDENT INVOLVING AN ACCUSOL 35 5L BAG. THE REPORTER STATES THAT THE ADDITIVE POST CAME OFF THE BAG COMPLETELY WHEN REMOVING THE BAG FROM THE OVERPOUCH . THE REPORTER STATES IT WAS NOT DUE TO MISHANDLING. NOT DISCOVERED DURING PATIENT USE.

    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 10I07G71

    Patients

    Seq Age Sex Outcome Treatment
    1