BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3260212 · Received August 1, 2013

    Report

    Report Number
    1416980-2013-20396
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    May 13, 2013
    Report Date
    July 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECIEVED FOR EVALUATION. REVIEW OF THE EVENT LOG IDENTIFIED THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. THE CAUSE WAS DETERMINED TO BE ONE OR MORE CYCLES ADVANCED TO THE NEXT FILL WHEN SLOW OR NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. THIS EVENT OCCURRED DURING THE THERAPY THAT WAS INITIATED ON 13 MAY 2013 AT 20:59:32. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 914ML, INDICATING THE HOME PATIENT (HP) DRAINED 914ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1500ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359883 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1