BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW RECIRCULATION VOLUME APDSET W/CASSETTE

    MDR report key: 2140031 · Received June 25, 2011

    Report

    Report Number
    1423500-2011-08361
    Event Type
    Malfunction
    Date Received
    June 25, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 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). THE ACTUAL SAMPLE WAS EVALUATED AND THE ISSUE WAS CONFIRMED AND WAS DETERMINED TO BE CAUSED BY FAULTY SEALING OF DYES USED FOR RADIOFREQUENCY SEALING AND THE EXTRACTION STATION ON THE PATIENT LINE MACHINES. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).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

    THIS IS AN INTERNATIONAL REPORT WHERE THE HOME PATIENT (HP) NOTICED THAT THE PATIENT LINE HAD SOME BUBBLES DURING THE DRAIN; LATER, WHEN HE WAS INFUSING, THE HP IDENTIFIED THAT THE LINE STARTED TO LEAK. THE PATIENT WAS INVOLVED. AT THIS MOMENT IT HAS NOT BEEN CONFIRMED IF THERE WAS PATIENT INJURY.

    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. 45SCHC

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE