BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3954927 · Received July 24, 2014

    Report

    Report Number
    1416980-2014-24035
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE HOMECHOICE 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 RITE (RETURNED INSTRUMENT TEST EVALUATION) FAILURE. THE EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND THE DEVICE PASSED, ALONG WITH ALL OF THE ELECTRICAL TESTING. DURING THE EVALUATION, THE FLUID WAS TRANSFERRED OUTSIDE OF THE RITE SPECIFIED LIMITS. THE VOLUMETRIC ACCURACY TEST THAT FOLLOWED SHOWED THAT THE DEVICE HAD FAILED. WHEN A TEST ARTICLE, PISTON FOAM, WAS INSTALLED, THE DEVICE PASSED THE ACCURACY CONFIRMATION TESTING. THE ORIGINAL PISTON FOAM WAS DETERMINED TO BE TOO DAMAGED TO PLACE BACK INTO THE DEVICE. THE INSPECTION SHOWED THAT THE PISTON FOAM WAS DETERIORATED. THE RESULTS OF THE EVALUATION CONCLUDED THE CAUSE OF THE FAILURE TO BE THE DETERIORATED PISTON FOAM. THE DOOR PISTON FOAM WAS TO BE REPLACED 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 INVESTIGATION, 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 (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED FLUID VOLUME ACCURACY TESTING. DEVICE FAILED DURING EVALUATION, NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435046 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1