BEUDAMED
    FDA Adverse Event Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2241470 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11961
    Date Received
    September 9, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 30, 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). SAMPLE IS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROTECTOR WAS NOT ASSEMBLED ON THE PATIENT LINE BUT IT WAS INSIDE THE PRIMARY PACKAGING. THIS IS A MANUFACTURING ISSUE-ASSEMBLY. THE ROOT CAUSE IS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS AN INTERNATIONAL REPORT OF A PATIENT THAT REPORTED ONE CASSETTE THAT DID NOT HAVE THE PROTECTOR CAP ON THE PATIENT LINE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX PLASTI ESTERIL, S.A. DE C.V. 83SFHC

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE