BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 2141682 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08409
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    December 3, 2007
    Report Date
    January 2, 2008
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE ISSUE WAS NOT CONFIRMED BECAUSE THERE WAS NOT ENOUGH INFORMATION; THEREFORE THE ROOT CAUSE COULD NOT BE DETERMINED. 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. 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 FDA-WARNING (B)(4).

    Description of Event or Problem · 1

    THE SPIKE HAD COME LOOSE FROM THE BAG OF ACCUSOL. IT WAS NOTICED BEFORE PATIENT USE. NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 07D05G70

    Patients

    Seq Age Sex Outcome Treatment
    1