BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3984091 · Received August 6, 2014

    Report

    Report Number
    1416980-2014-25452
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    April 20, 2014
    Report Date
    July 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED AND EVALUATED. ALL RETURNED HC DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE HC PASSED ELECTRICAL TESTING, BUT FAILED A FUNCTIONAL TEST FOR AN UNRELATED ISSUE. THE EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND THE DEVICE PASSED. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED DURING THE REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE OF THE IIPV EVENT COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HIGH DRAIN ERROR 101 (NIGHT DRAIN #1) ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. A HIGH DRAIN ALARM OCCURS WHEN A PATIENT HAS DRAINED A VOLUME EQUAL TO 200% OR GREATER THAN THE PATIENTS FILL VOLUME IN STANDARD MODE. THE ALARM OCCURRED ON (B)(6) 2014 AT 02:07:58. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459397 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR