BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2945513 · Received February 6, 2013

    Report

    Report Number
    1416980-2013-03025
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 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 REPORT OF A SYSTEM ERROR 2240 WAS CONFIRMED. THE ROOT CAUSE WAS "SUPPLY BAG DISCONNECTED WITHOUT FALLING". THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 2. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CYCLE THE POWER ON THE HC TO RECEIVE A SYSTEM ERROR 2367. THE TSR HAD THE HP TURN THE HC OFF AGAIN. THE TSR EXPLAINED BOTH SYSTEM ERRORS TO THE HP. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED PRIOR TO CONNECTING AND NO PATIENT EXTENSION LINES WERE IN USE. THE PATIENT LINE HAD NOT DISCONNECTED FROM THE TRANSFER SET. THE PATIENT DID NOT INITIATE THERAPY BEFORE CONNECTING AND HAD NOT DISCONNECTED PRIOR TO THE ALARM. THE SUPPLIES HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE HP SAID THAT THE SUPPLY BAG CAME LOOSE FROM THE SUPPLY LINE AS IT WAS NOT CONNECTED PROPERLY. THE TSR ADVISED THE HP MUST START OVER WITH ALL NEW SUPPLIES ON HC. THE HP UNDERSTOOD. PROPER PROCEDURES WERE REVIEWED. THERE WERE NO SAMPLES OR LOT NUMBERS AVAILABLE. 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
    50472 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HOMECHOICE