BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2970372 · Received February 20, 2013

    Report

    Report Number
    1416980-2013-04276
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 1, 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 FOR A SYSTEM ERROR 2240 (AIR IN SET) IS CONFIRMED; BECAUSE THE CUSTOMER REPORTED HEATER BAG BECAME DISCONNECTED, WHICH IS A KNOWN CAUSE OF SYSTEM ERROR 2240. THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT CONDUCTED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REPORTING A SYSTEM ERROR 2240/2367 (AIR IN SET) DURING FILL 3 OF 5 ON THE HOMECHOICE (HC). THE CAREGIVER (CG) STATED THE HEATER BAG BECAME DISCONNECTED. THE CG STATED THEY TURNED OFF THE HOMECHOICE (HC) AND TURNED IT BACK ON AND GOT SYSTEM ERROR 2367. TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE SYSTEM ERROR 2367 WAS THE END OF THERAPY ALARM. THE CG STATED THE HOME PATIENT (HP) WILL NOT RESTART THERAPY TONIGHT AND MAY CALL BACK IN THE MORNING TO REMOVE THE CASSETTE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73351 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HOMECHOICE