BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2791907 · Received October 15, 2012

    Report

    Report Number
    1416980-2012-02480
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM OF USE ERROR WAS CONFIRMED BASED ON THE CUSTOMER REPORT. HOWEVER, THE ROOT CAUSE OF THE USE ERROR WAS UNDETERMINED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A CHECK LINES AND BAGS THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING USE, WHILE THE PATIENT WAS CONNECTED. THE HOME PATIENT (HP) STATED THEY RECEIVED CHECK LINES AND BAGS ALARM IN DWELL 5 OF 5, AND THE FINAL BAG HAD FLUID. HP STATED THEY CHANGED THE FINAL BAG, WHILE CONNECTED, PRIOR TO CALLING. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) HELPED CALLER END THERAPY, TOLD CALLER TO CALL THE RN IN REGARDS TO THE MISSED THERAPY AND CHANGING BAG WHILE CONNECTED TO MACHINE. THE CALLER WILL CALL BACK FOR ANY PROBLEMS OR QUESTIONS. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION 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 HOMECHOICE