BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2962445 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03848
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE EXTERNAL AND INTERNAL VISUAL INSPECTION WAS PERFORMED AND REVEALED NO PROBLEMS. THE DEVICE PASSED THE VOLUMETRIC ACCURACY AND TEMPERATURE VERIFICATION TESTS. THE RITE THERAPY PARAMETERS WERE PROGRAMMED AND THE DEVICE SUCCESSFULLY COMPLETED THE TESTING. THE VOLUMES TRANSFERRED DURING FILLS AND DRAINS WERE MONITORED AND WERE FOUND TO BE WITHIN SPECIFICATIONS. AN INSPECTION PERFORMED ON THE DOOR AND PISTON REVEALED NO ANOMALIES. THE REPORTED ISSUE OF RITE FAILURE (FILL 1, DRAIN1, FILL 2, DRAIN 2 VOLUMETRIC OUT OF LIMITS) WAS CONFIRMED BY DUPLICATION DURING RITE FUNCTIONAL TESTING. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE INCORRECT PROGRAMMED RITE THERAPY FILL VOLUME. THE DEVICE WAS DETERMINED TO MEET SPECIFICATIONS FOR THE REPORTED ISSUE. DEVICE WILL BE SENT TO SERVICE AREA FOR SERVICING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE OF THE HOMECHOICE (HC) MACHINE, IT FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO A RITE - THERAPY MONITORED VOLUME FAILED PERFORMANCE SPEC. THE CUSTOMER DISCONTINUED USE OF THE HC MACHINE AND RETURNED IT TO BAXTER (B)(4). THERE WAS NO REPORT OF PATIENT/USER INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64958 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1