BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3910853 · Received July 2, 2014

    Report

    Report Number
    1416980-2014-21353
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE WAS RETURNED, AND A DEVICE ANALYSIS IS CURRENTLY UNDERWAY. UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED ISSUE. THE EXTERNAL/INTERNAL INSPECTION WAS PERFORMED. THE INTERNAL INSPECTION FOUND AN UNRELATED ISSUE OF A POSITIVE IN TUBING BEING DAMAGED, BUT IT WAS REPLACED AND THE PNEUMATIC SYSTEM FUNCTIONED WITHOUT ISSUES. THE HC PASSED THE RITE (RETURNED INSTRUMENT TEST EVALUATION) ELECTRICAL TESTING. THE DEVICE PASSED TEMPERATURE VERIFICATION TESTING. THE DEVICE FAILED RITE FUNCTIONAL TESTING DUE TO THE VOLUMETRIC ACCURACY BEING OUTSIDE OF SPECIFICATIONS. THE INSPECTION SHOWED THAT THE PISTON FOAM WAS DETERIORATED. THE RESULTS OF THE EVALUATION REVEALED THE CAUSE OF THE FAILURE TO BE A DETERIORATED PISTON FOAM. THE PISTON FOAM WAS TO BE SCRAPPED AND THE DEVICE WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER SERVICE TECHNICIAN DETERMINED THAT THE HC FAILED VOLUMETRIC ACCURACY TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387789 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1