BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3242412 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19412
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    May 9, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 USE ERROR, TIDAL TOTAL ULTRA FILTRATION (UF) REMOVAL SET TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER?S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. 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 MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, TWO INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENTS WAS/WERE IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) AT 2013 00:39:14. DURING NIGHT DRAIN CYCLE NINE, THE PATIENT'S ULTRAFILTRATION READING WAS 1669 ML, INDICATING THE HOME PATIENT (HP) DRAINED 1339 ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2200 ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342911 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1