BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3827583 · Received May 22, 2014

    Report

    Report Number
    1416980-2014-16548
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    January 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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 AN EVALUATION WAS COMPLETED. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. THE INCREASE INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HIGH DRAIN ERROR 103 (NIGHT DRAIN #3) 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 11:50:50 DURING THE PATIENT'S NIGHT DRAIN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305669 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR