BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 2133733 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07815
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    January 11, 2010
    Report Date
    January 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SAMPLE RETURNED AND EVALUATED. THE REPORTED PROBLEM WAS CONFIRMED. THE CLAMPEX CONNECTOR AND VALVE WAS FOUND TO BE DETACHED FROM THE SOLUTION BAG. THE ROOT CAUSE OF THE PROBLEM COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. 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. 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 FDA-WARNING (B)(4).

    Description of Event or Problem · 1

    THIS IS A CASE THAT WAS REPORTED ON THE (B)(6) 2010 TO A BAXTER CUSTOMER SERVICES REPRESENTATIVE FROM ROYALS HOSPITAL IN BELFEST BY A BIOENGINEER. IT WAS REPORTED THAT THE BOTTOM CONNECTOR WAS ALMOST FULLY DISCONNECTED FROM THE ACCUSOL BAG. ONE SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 09A06G70

    Patients

    Seq Age Sex Outcome Treatment
    1