BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4223120 · Received November 4, 2014

    Report

    Report Number
    1416980-2014-38662
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE FAILED FUNCTIONAL TESTING AND ACCURACY CONFIRMATION TESTING. AN INSPECTION REVEALED THAT THERE WAS DETERIORATED PISTON FOAM. THE ORIGINAL PISTON FOAM WAS REMOVED AND A TEST ARTICLE FOAM WAS INSTALLED INTO THE DEVICE AND ACCURACY WAS PERFORMED AND PASSED. THE DEVICE WAS THEN TESTED FOR TEMPERATURE VERIFICATION AND PASSED ALL TESTING PERTAINING TEMPERATURE VERIFICATION. THE DEVICE ALSO PASSED ELECTRICAL TESTING. THE SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE CAUSE OF THE PROBLEM WAS DETERIORATED PISTON FOAMS; THEREFORE THE PISTON FOAM WAS REPLACED TO RESOLVE THE ISSUE. THIS ISSUE IS CURRENTLY BEING ADDRESSED THROUGH A CAPA. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECHNICIAN DETERMINED THE DEVICE FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING FOR FLUID VOLUME ACCURACY. DEVICE FAILED DURING EVALUATION, NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705700 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1