BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3950914 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23693
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. AN INTERNAL/EXTERNAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. TEMPERATURE VERIFICATION 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. THE DEVICE FAILED ACCURACY CONFIRMATION TESTING WITH THE ORIGINAL PISTON FOAM INSTALLED. INSPECTION OF THE DOOR ASSEMBLY FOUND THAT THE PISTON FOAM WAS DETERIORATED AND THE DOOR PISTON WAS CRACKED. A TEST ARTICLE, PISTON FOAM, WAS INSTALLED AND THE DEVICE WAS ABLE TO PASS THE ACCURACY TESTING. THE DEVICE FAILED THE ACCURACY TEST AGAIN WHEN THE ORIGINAL PISTON FOAM WAS REINSTALLED. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE THE DETERIORATED PISTON FOAM AND CRACKED DOOR PISTON. THE PISTON FOAM AND DOOR PISTON WERE SCRAPPED. 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428589 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1