BEUDAMED
    FDA Adverse Event Summary report: N

    HOMECHOICE, DOMESTIC 120V

    MDR report key: 1062857 · Received June 11, 2008

    Report

    Report Number
    1423500-2008-00472
    Date Received
    June 11, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 12, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ADDITIONAL 510(K): K923065.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER TECHNICAL SERVICES AND REPORTED FEELING OVERFILLED IN DWELL 2 OF THERAPY WITH THE HOMECHOICE (HC) MACHINE. THE PT WAS EXPERIENCING SYMPTOMS OF ABDOMINAL DISCOMFORT, ABDOMINAL PAIN, ABDOMINAL DISTENTION, ABDOMINAL BLOATING, AND DIFFICULTY BREATHING. PRIOR TO CALLING BAXTER, THE HP HAD DRAINED 4017 ML. THE PATIENT'S PROGRAMMED FILL VOLUME WAS 2500 ML. THE HOME PT ELECTED TO RESUME THERAPY AND GO INTO FILL CYCLE 3. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT ACCORDING TO THE HOME PT'S NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE, DOMESTIC 120V 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR