BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2981271 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04817
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 15, 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). THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR 2367 WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2367, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 1. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED PRIOR TO CONNECTION AND NO PATIENT EXTENSIONS WERE IN USE. ALL OF THE BAGS WERE PROPERLY CONNECTED AND THERE WERE NO OPEN CLAMPS ON UNUSED LINES. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES AND THEY HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE PATIENT HAD DISCONNECTED PRIOR TO THE ALARM. PROPER DISCONNECT PROCEDURES WERE USED, AND THE PATIENT RECONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) THE POWER CYCLE THE MACHINE. THE TSR EXPLAINED THAT THE MACHINE ALARMED DUE TO A POSSIBLE INTRODUCTION OF AIR INTO THE LINES. THE TSR ADVISED THE HP WOULD HAVE TO START OVER WITH NEW SUPPLIES AND CONTACT HIS REGISTERED NURSE ABOUT THE EVENT. PROPER PROCEDURES WERE REVIEWED. 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
    83970 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR HOMECHOICE