BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3864039 · Received June 10, 2014

    Report

    Report Number
    1416980-2014-18554
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AND THE ISSUE WAS IDENTIFIED THROUGH REVIEW OF THE EVENT HISTORY LOGS. THE CAUSE WAS DETERMINED TO BE A USE ERROR OF SETTING THE TIDAL TOTAL UF REMOVAL TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER¿S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014 AT 10:28:11. DURING NIGHT DRAIN CYCLE SEVEN, THE PATIENT'S ULTRAFILTRATION READING WAS 1395ML, INDICATING THE HOME PATIENT (HP) DRAINED 1065ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1100ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341306 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1