BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3243641 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19513
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AND THE REPORTED ISSUE WAS CONFIRMED THROUGH THE REVIEW OF THE LOGS. THE CAUSE WAS DETERMINED TO BE A USE ERROR, AS THE TIDAL TOTAL ULTRA FILTRATION (UF) REMOVAL WAS SET TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER'S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. IT ALSO WARNS THAT "THIS COULD RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION." A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPROT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. THIS OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013, DURING NIGHT DRAIN CYCLE FIVE. THE PATIENT'S ULTRAFILTRATION READING WAS 2131ML, INDICATING THE HOME PATIENT (HP) DRAINED 1816ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2100ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343718 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR