BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3841507 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17475
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED ISSUE. INTERNAL AND EXTERNAL INSPECTIONS WERE PERFORMED AND REVEALED DISINTEGRATED PISTON FOAM, BUT NO MOISTURE WAS FOUND WITHIN THE DEVICE. TEMPERATURE CONFIRMATION TESTING WAS PERFORMED AND THE DEVICE PASSED. RITE (RETURNED INSTRUMENT TEST EVALUATION) ELECTRICAL TESTING WAS CONDUCTED AND THE DEVICE PASSED. THE DEVICE FAILED RITE FUNCTIONAL TESTING AS FLUID WAS TRANSFERRED ABOVE SPECIFICATION LIMITS. TEST PISTON FOAM WAS INSTALLED, AND THE DEVICE PASSED THE ACCURACY CONFIRMATION TESTING. THE CAUSE OF THE RITE FAILURE WAS DUE TO DISINTEGRATED PISTON FOAM. THE PISTON FOAM WAS SCRAPPED AND THE DEVICE WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECHNICIAN DETERMINED THE HOMECHOICE FAILED FLUID VOLUME ACCURACY TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318323 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1