BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2896494 · Received January 4, 2013

    Report

    Report Number
    1416980-2013-00260
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 16, 2012
    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; IT WAS REPORTED THAT THE CONNECTION TO THE SUPPLY BAG WAS LOOSE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) DURING DWELL 2 OF 4 THE HOME CHOICE (HC). THE SUPPLY BAG CONNECTION WAS LOOSE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HOME PATIENT (HP) TO CLOSE ALL THE CLAMPS. THE HP CYCLED THE POWER OFF/ON TO CLEAR THE SYSTEM ERROR 2240 FOLLOWED BY A SYSTEM ERROR 2367 ENDING THERAPY. THE TSR HAD THE HP DISCONNECT USING ASEPTIC TECHNIQUE AND REMOVED THE CASSETTE. THE HP WOULD NOTIFY THE PERITONEAL DIALYSIS NURSE (PDN) OF THE MISSED THERAPY. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4359 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR HOMECHOICE