BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2936266 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02371
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 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

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING AN ALARM DURING FILL 1 OF 4 ON THE HOMECHOICE (HC).THE HOME PATIENT (HP) STATED THEY DISCONNECTED/RECONNECTED THE HEATER BAG. THE HP ALSO STATED WHEN THEY DISCONNECTED THE BAG SOLUTION CAME OUT OF IT. THE HP STATED WHEN THEY RECONNECTED THE HEATER BAG AND STARTED THE FILL, NO SOLUTION WOULD COME OUT OF THE PATIENT LINE. THE HP ASKED IF THEY SHOULD START OVER WITH NEW SUPPLIES AT THAT POINT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED IT WAS NOT RECOMMENDED TO DISCONNECT AND RECONNECT BAGS WHILE THE HOME PATIENT (HP) WAS DISCONNECTED. THE TSR RECOMMENDED THE HP CONTACT BAXTER AT THE TIME OF THE ALARM AND BAXTER WOULD ASSIST WITH TROUBLESHOOTING. 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
    41317 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE