BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW RECIRCULATION VOLUME APDSET W/CASSETTE

    MDR report key: 2070715 · Received April 27, 2011

    Report

    Report Number
    1423500-2011-05086
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    PLASTI ESTERIL, S.A. DE C.V.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT OF A LEAK WAS REVIEWED AND THERE WERE NO EVENTS THAT REPRESENTED A QUALITY ISSUE IN THE PRODUCT. THERE WAS NO SAMPLE SO A EVALUATION COULD NOT BE PERFORMED; THEREFORE, THE EVENT WAS NOT CONFIRMED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    THE HOME PATIENT'S MOTHER CALLED TO BAXTER'S (B)(4) TO NOTIFY THAT SHE IDENTIFIED ONE CASSETTE WHICH PRESENTED A LEAK IN THE PATIENT LINE JUST AFTER STARTING THE THERAPY. THE SET WAS REPLACED AND NO PROBLEMS WERE REPORTED AFTER THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW RECIRCULATION VOLUME APDSET W/CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX PLASTI ESTERIL, S.A. DE C.V. 04SAHC

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE CYCLER