BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2893199 · Received January 2, 2013

    Report

    Report Number
    1416980-2013-00053
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 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. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WAS NOT CONDUCTED. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) DURING DWELL 3 OF 4 ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) DETERMINED THAT THE BLUE CLAMP HANGING OFF OF THE ORGANIZER WAS OPEN. THE TSR EXPLAINED THAT IF THERE WAS NO BAG CONNECTED TO THE CLAMP, IT SHOULD ALWAYS BE CLOSED. THE TSR HAD THE CAREGIVER (CG) CLOSE ALL THE CLAMPS TO BAGS/PATIENT LINE/TRANSFER SET, CYCLE THE POWER OFF/ON, TO THE SE 2367, CYCLE THE POWER OFF/ON, PRESS GO TO START, LOAD THE SET AND REMOVE THE CASSETTE. THE TSR ADVISED THE CG TO DISPOSE OF THE CURRENT SUPPLIES ATTACHED AND EITHER CONTINUE WITH ALL NEW SUPPLIES OR MANUAL BAGS. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR HOMECHOICE