BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2822545 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04276
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 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 (SE) 2240 (AIR IN SET) IS CONFIRMED BECAUSE THE PATIENT REPORTED HAVING A CLAMP OPEN ON AN UNUSED SUPPLY LINE DURING THERAPY, WHICH IS USE ERROR THAT CAN CAUSE SYSTEM ERROR 2240 ALARMS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) DETERMINED THE HOME PATIENT LEFT THE BLUE CLAMP LINE OPEN. THE CAUSE WAS DETERMINED TO BE USE ERROR. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE PREVENTION OF THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN LINE) DURING DWELL 3 OF 4 ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) DETERMINED THAT TWO BAGS WERE CONNECTED, ONE ON THE RED CLAMP LINE AND ONE ON THE WHITE CLAMP LINE. THE TSR DETERMINED THE HOME PATIENT (HP) HAD LEFT THE BLUE CLAMP LINE OPEN AND EXPLAINED THE IMPORTANCE OF CLOSING ANY CLAMPS IN WHICH THE BAGS ARE NOT ATTACHED. THE TSR INSTRUCTED THE HP TO CLOSE ALL THE CLAMPS TO THE BAGS/PATIENT LINE/TRANSFER SET, CYCLE THE POWER OFF/ON TO GET THE SYSTEM ERROR 2367, CYCLE THE POWER OFF/ON AGAIN, PRESS GO TO START, AND AT THE LOAD THE SET, OPEN THE CASSETTE DOOR. THE TSR ADVISED THE HP TO DISPOSE OF THE CURRENT SUPPLIES AND CONTINUE WITH EITHER MANUAL BAGS OR ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR HOMECHOICE