BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2781548 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-02103
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE FOR THE ISSUE OF FAILED HOMECHOICE (HC) RETURN INSTRUMENT TEST/EVALUATION (RITE) FAILED FUNCTIONAL TEST FOR THERAPY MONITORED VOLUME FAILED PERFORMANCE SPEC: FILL 1 16.1 ML, DRAIN 1 15.2 ML. DEVICE (RITE SPECIFICATION LIMITS OF 774 ML - 821 ML). THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE COMPLETED SEVERAL SHORT SIMULATED THERAPIES (RITE THERAPY) WITH NO PROBLEMS ENCOUNTERED. DURING THERAPIES THE FILL AND DRAIN VOLUMES WERE MONITORED ON THE DEVICE AND REVEALED PROPER AMOUNT VOLUMES WERE DELIVERED DURING FILL AND DRAIN PHASES. THE ASSIGNABLE CAUSE WAS UNDETERMINED. THE DEVICE WILL BE SENT TO SERVICING.

    Description of Event or Problem · 1

    THE PRODUCT ANALYSIS LABORATORY (PAL) DETERMINED THE HOMECHOICE MACHINE SYSTEM FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO A RITE - THERAPY MONITORED VOLUME FAILED PERFORMANCE SPEC: FILL 1: 16.1 ML, DRAIN 1: 15.2 ML. (RITE SPECS ARE 774.0 - 821.0 ML.) RITE TEST FAILURE, NO PATIENT INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1