BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2925093 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01620
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THE HOME PATIENT (HP) HAD NO ALARMS AND WAS IN FILL 3 OF 3 ON A HOME CHOICE (HC), WHEN HE DISCONNECTED AND RECONNECTED THE CASSETTE LINE. THE HP REALIZED THE BAG ON THE HEATER WAS EMPTY AND THE SUPPLY BAG HAD FLUID. THEN THE HP DISCONNECTED/RECONNECTED THE CASSETTE LINES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED, ASSISTED TO END THERAPY AND ADVISED TO LET THE REGISTERED NURSE (RN) KNOW THAT THE HP SWITCHED THE CASSETTE LINES DURING THERAPY. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28944 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HOMECHOICE