BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4221394 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38570
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 EVALUATION WAS COMPLETED. NO ABNORMALITIES WERE IDENTIFIED DURING INTERNAL/EXTERNAL INSPECTIONS. TEMPERATURE VERIFICATION TESTING PASSED. THE DEVICE PASSED RITE (RETURNED INSTRUMENT TEST EVALUATION) ELECTRICAL TESTING, BUT FAILED RITE FUNCTIONAL TESTING AS FLUID WAS TRANSFERRED ABOVE SPECIFICATION LIMITS. FURTHER INSPECTION OF THE DOOR ASSEMBLY REVEALED DETERIORATED PISTON FOAM AND A CRACKED DOOR PISTON. TEST PISTON FOAM WAS INSTALLED AND THE DEVICE WAS ABLE TO PASS VOLUMETRIC ACCURACY TESTING. A SERVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY ISSUES IN THE PREVIOUS SERVICE EVENTS THAT WOULD HAVE CONTRIBUTED TO THE VOLUMETRIC ACCURACY ISSUE WAS DETERMINED TO BE DETERIORATED PISTON FOAM AND A CRACKED DOOR PISTON. A CAPA WAS INITIATED TO INVESTIGATE THE ISSUE. 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 DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED MANUAL VOLUMETRIC ACCURACY TESTING. THERE WAS NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701190 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1