BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3833868 · Received May 27, 2014

    Report

    Report Number
    1416980-2014-17118
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 5, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. ALL RETURNED HOMECHOICE (HC) DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE DEVICE PASSED RITE TESTING. NO ABNORMALITIES WERE IDENTIFIED DURING INTERNAL/EXTERNAL INSPECTIONS. THE PROBLEM OF A HIGH DRAIN ALARM WAS IDENTIFIED IN AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 105 (NIGHT DRAIN 5) ALARM WAS IDENTIFIED IN THE LOG. THE ALARM OCCURRED ON (B)(6) 2014 AT 11:41:19. THIS MEETS INCREASED INTRA PERITONEAL VOLUME (IIPV) CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310863 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR