BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2942443 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02879
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 27, 2013
    Report Date
    January 27, 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). THIS 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 GLOBAL TECHNICAL SERVICES (GTS) REGARDING AN ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING FILL. THE CG STATED SHE NOTICED THE HEATER BAG DISCONNECTED FROM THE SETUP. THE CG STATED SHE CHANGED OUT THE HEATER BAG AND THE CASSETTE FOR NEW SUPPLIES BUT DID NOT CHANGE OUT THE SUPPLY BAGS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INFORMED THE CG WHEN STARTING OVER WITH NEW SUPPLIES THAT ALL SUPPLIES NEED TO BE CHANGED OUT. THE TSR ADVISED THE CG TO START OVER WITH ALL NEW SUPPLIES AND INFORM THE REGISTERED NURSE (RN). THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47095 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR HOMECHOICE