BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3822005 · Received May 20, 2014

    Report

    Report Number
    1416980-2014-16297
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. INTERNAL AND EXTERNAL INSPECTIONS WERE PERFORMED AND THE DEVICE PASSED. TEMPERATURE CONFIRMATION 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. TEST PISTON FOAM WAS INSTALLED, AND THE DEVICE PASSED THE ACCURACY CONFIRMATION TESTING. FURTHER INSPECTION OF THE DOOR ASSEMBLY REVEALED THAT THE DOOR PISTON WAS CRACKED. THE CAUSE OF THE RITE FAILURE WAS DUE TO DETERIORATED PISTON FOAM AND A CRACKED DOOR PISTON. THE PISTON FOAM AND DOOR PISTON WERE SCRAPPED 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 BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300431 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1