BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3150548 · Received June 6, 2013

    Report

    Report Number
    1416980-2013-14494
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. (B)(4). THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS USE ERROR; TIDAL TOTAL ULTRA-FILTRATION (UF) REMOVAL WAS SET TOO LOW. HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE GIVES INSTRUCTIONS ABOUT THE UF TARGET AND ALARM. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013 AT 22:28:54. DURING NIGHT DRAIN CYCLE 13, THE PATIENT'S ULTRAFILTRATION READING WAS 1889ML, INDICATING THE HOME PATIENT (HP) DRAINED 1289ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251307 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1