BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2983017 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04912
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS CONFIRMED. THE ROOT CAUSE WAS TUBING LEAK. 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A LEAK, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DRAIN THE HOME PATIENT (HP) STATED SHE WENT TO CONNECT TO THE PATIENT LINE AND WATER WAS LEAKING OUT. SHE DID NOT CONNECT, BUT SHE PUSHED THE GO BUTTON TO THE INITIAL DRAIN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED TO END THERAPY AND INFORMED THEM TO START OVER USING NEW SUPPLIES. THE PATIENT WAS NOT CONNECTED EITHER AT THE TIME OF THE ALARM OR OBSERVED AIR. THE PATIENT LINE DID NOT BECOME SEPARATED FROM THE TRANSFER SET. THE PATIENT DID NOT DISCONNECT ANY TIME PRIOR TO THE ALARM OR OBSERVED AIR. ALL BAGS WERE PROPERLY CONNECTED. THERE WERE NO OPEN CLAMPS ON UNUSED SUPPLY LINES. THE HOME CHOICE SET WAS NOT BEING REUSED. THE PATIENT DID NOT HAVE ANY PETS THAT CAUSED DAMAGE TO THE SUPPLIES. THERE WAS NO DAMAGE TO THE OVERPOUCH OR CARTON IN WHICH THE CASSETTE WAS DELIVERED. A SHARP OBJECT WAS NOT USED TO ASSIST IN THE OPENING OF THE CARTON OR OVERPOUCH. 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. THE HP WOULD COMPLETE THERAPY WITH NEW SUPPLIES. 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
    86348 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOME CHOICE