BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2983142 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04926
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS CONFIRMED. THE ROOT CAUSE WAS LOOSE CONNECTION. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. PER THE CUSTOMER THE SAMPLE WAS NOT AVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A SYSTEM ERROR 2240 THAT APPEARED ON THE HOME CHOICE (HC) DURING DRAIN 3 OF 5. PER THE HOME PATIENT (HP) THE PATIENT LINE CAME UNDONE AND DISCONNECTED IN DRAIN 3/5 AND WAS ALARMING. THE PATIENT WAS NOT CONNECTED EITHER AT THE TIME OF THE ALARM OR OBSERVED AIR. THE PATIENT DID NOT PRESS GO TO START THERAPY BEFORE CONNECTING. A DUMMY TUMMY WAS NOT BEING USED. THE PATIENT DID DISCONNECT PRIOR TO THE ALARM OR OBSERVED AIR. ALL BAGS WERE PROPERLY CONNECTED. THERE WERE NO OPEN CLAMPS ON UNUSED SUPPLY LINES. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR AN ASSIST DEVICE USED TO MAKE THE CONNECTIONS. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE REPORTER. 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
    87726 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOME CHOICE