BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1932417 · Received December 17, 2010

    Report

    Report Number
    1423500-2010-07017
    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). A BATCH REVIEW COMPLETED AND WAS ACCEPTABLE. A TREND REVIEW WAS COMPLETED AND THERE WAS NO SIGNIFICANT TREND. NO SAMPLE AVAILABLE FOR ANALYSIS. THE BAXTER (B)(4) ARE CURRENTLY INVESTIGATING A REDESIGN TO THIS CLAMPEX CONNECTOR. 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.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER FROM THE CUSTOMER. THE CUSTOMER REPORTED AN ACCUSOL BAG HAS A BROKEN CONNECTOR. THIS WAS BEFORE THERAPY THERE WAS NO PATIENT INVOLVEMENT.

    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