BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2791914 · Received October 15, 2012

    Report

    Report Number
    1416980-2012-02488
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    October 6, 2012
    Report Date
    October 6, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    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. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - REUSE OF SINGLE-USE PRODUCT ISSUE. THE COMPLAINT IS CONFIRMED BECAUSE IT WAS REPORTED THAT THE PATIENT SWITCHED ONLY A SOLUTION BAG INSTEAD OF REPLACING THE ENTIRE SET UP. THE ROOT CAUSE IS UNDETERMINED. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING AN ALARM ON A HOME CHOICE (HC) WHERE THE HOME PATIENT (HP) WAS IN PRIME AND CONNECTED, THEN DISCONNECTED THE FINAL BAG AS IT WAS LEAKING AND PUT A NEW BAG ON THE LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE REGISTERED NURSE (RN) TO HAVE THE HP DISCONNECT AND DISCARD THE SUPPLIES. THE RN WAS AWARE OF STERILITY ISSUES. THE TSR ASKED THE RN TO CHECK THE THERAPY LOG TO SEE IF THE HP EVER STARTED THERAPY. THE RN WOULD CALL BACK IF ANY PROBLEMS OR QUESTIONS. 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 71 YR HOMECHOICE