BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOL

    MDR report key: 2032985 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03815
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - CASTLEBAR
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SAMPLE WAS RECEIVED AND THE COMPLAINT CONFIRMED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE ROOT CAUSE IS DUE TO MIS-HANDLING OF THE PRODUCT. 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 PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THERE WAS A BROKEN SEAL ON AN ACCUSOL BAG. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSOL DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BAXTER HEALTHCARE - CASTLEBAR 10I114G71

    Patients

    Seq Age Sex Outcome Treatment
    1