BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4250328 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40449
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS COMPLETED. THIS IS AN ANCILLARY SERVICE EVENT. THE HIGH DRAIN ERROR 104 ALARM WAS IDENTIFIED IN THE EVENT HISTORY LOG REVIEW. AN INTERNAL AND EXTERNAL VISUAL INSPECTION WAS PERFORMED. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE INCREASED INTRAPERITONEAL VOLUME EVENT COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 104 (NIGHT DRAIN #4) ALARM WAS IDENTIFIED IN THE LOG. A HIGH DRAIN ALARM OCCURS WHEN A PATIENT HAS DRAINED A VOLUME EQUAL TO 200% OR GREATER THAN THE PATIENT¿S PRESCRIBED FILL VOLUME. THE ALARM OCCURRED ON (B)(6) 2014 AT 00:21:35. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737617 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR