BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2222614 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11219
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BAXTER HEALTHCARE- SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER, AND THEREFORE A SAMPLE EVALUATION WILL NOT BE COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT COULD NOT BE CONFIRMED FOR THE REPORTED ISSUE. ROOT CAUSE WAS UNDETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A PROGRAM CHANGE BY THE HOME CHOICE (HC) DURING DWELL CYCLE. THE HOME PATIENT (HP) MAY HAVE GOTTEN INTO THE PROGRAM MENU, AND THE HC NOW DISPLAYED DWELL 1 OF 121. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) REFERRED THE HP TO AN ON-CALL NURSE TO REVIEW AND ADJUST THE THERAPY SETTING. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE- SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1