BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4191034 · Received October 21, 2014

    Report

    Report Number
    1416980-2014-36850
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    July 30, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AND THE REPORTED ISSUE WAS VERIFIED THROUGH THE REVIEW OF THE EVENT HISTORY LOGS. RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND PASSED. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. 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 ERROR105 (NIGHT DRAIN #5) ALARM WAS IDENTIFIED IN THE LOG. THE HIGH DRAIN ALARM INDICATES THAT THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE, MEETING INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. THE ALARM OCCURRED ON (B)(6) 2014 AT 02:58:27. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668937 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR