BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2925798 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01683
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE DEVICE AND THE REPORTED CONDITION WAS NOT CONFIRMED; THE ROOT CAUSE COULD NOT BE DETERMINED. AN EVENT HISTORY LOG REVIEW WAS PERFORMED WITH NO ISSUES NOTED. A SERVICE HISTORY REVIEW WAS PERFORMED WHICH REVEALED PREVIOUS SERVICE EVENTS DID NOT CONTRIBUTE TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE DEVICE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL, RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER NEW ZEALAND REGARDING A BURNT ODOR COMING FROM A HOMECHOICE (HC) MACHINE. THE HOME PATIENT (HP) STATED THE DEVICE SMELLED LIKE "WIRES BURNING INSIDE THE HC." THE TECHNICAL SERVICES REPRESENTATIVE (TSR) ARRANGED FOR THE DEVICE TO BE SWAPPED AND THE HP WOULD CONTINUE THERAPY MANUALLY UNTIL THE NEW DEVICE WAS RECEIVED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30044 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1