BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 2133156 · Received June 19, 2011

    Report

    Report Number
    1423500-2011-07802
    Event Type
    Malfunction
    Date Received
    June 19, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 24, 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). A 510K 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 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S. THE DEVICE HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE. THE REPORTED ISSUE WAS CONFIRMED OF A DEFECT CAUSED BY FAULTY SEALING OF DYES USED FOR RADIOFREQUENCY SEALING AND THE EXTRACTION STATION ON THE PATIENT LINE MACHINES. THE CAUSE WAS DETERMINED TO BE MANUFACTURING ISSUE. A BATCH REVIEW WAS PERFORMED WITH NO ISSUES FOUND. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6), THE PATIENT NOTIFIED THE BAXTER CUSTOMER SERVICE TEAM THAT HE IDENTIFIED 2 CASSETTES FROM THE PRODUCT DELIVERED IN (B)(6) WHICH PRESENTED A LEAK OF THE SOLUTION DURING INSTALLATION CHECKING. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS ADDRESSING CASSETTE 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX PLASTI ESTERIL, S.A. DE C.V. 41SCHC

    Patients

    Seq Age Sex Outcome Treatment
    1