BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3132247 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13484
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS UNAVAILABLE FOR ANALYSIS; THEREFORE, NO EVALUATION COULD BE PERFORMED. PROPER USER INSTRUCTIONS ARE ADDRESSED IN "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE" WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. PER BAXTER LABELING, ALL PRINTED POUCHES FOR DISPOSABLE PRODUCTS INTENDED FOR SINGLE USE ARE LABELED WITH "THIS DEVICE IS INTENDED FOR SINGLE USE ONLY." A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR THE UNRELATED ALARM THE HOME PATIENT (HP) DISCONNECTED THE BAG FROM THE SUPPLY LINE AND CONNECTED THAT BAG TO THE FINAL LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE HP CANNOT JUST DISCONNECT A BAG AND RECONNECT IT TO ANOTHER LINE DUE TO A POSSIBLE INTRODUCTION OF AIR INTO THE SYSTEM. THE TSR ASSISTED THE HP WITH ENDING THE THERAPY. THE HP WAS GOING TO START THE THERAPY OVER USING ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236016 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