BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3841608 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17502
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB. INTERNAL AND EXTERNAL VISUAL INSPECTIONS PERFORMED REVEALED NO PROBLEMS. IT WAS DETERMINED THAT THE DEVICE DID NOT MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER HOMECHOICE RETURN INSTRUMENT TEST/ EVALUATION (RITE) TESTING, AS THE DEVICE PASSED THE HOMECHOICE RITE ELECTRICAL TEST AND FAILED THE HOMECHOICE RITE FUNCTIONAL TEST. THE DEVICE PASSED TEMPERATURE VERIFICATION AND FAILED ACCURACY CONFIRMATION. THE CAUSE WAS DETERMINED TO BE RELATED TO THE COPPER MESH PAD MAKING INSUFFICIENT CONTACT WITH HEATSINK COMPOUND. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED ISSUE. THE DOOR AND PISTON ASSEMBLIES WERE TO BE SERVICED. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED FLUID VOLUME ACCURACY TESTING. THE DEVICE FAILED DURING EVALUATION WITH NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317999 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1