BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3243495 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19497
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE EVENT HISTORY LOG REVIEW, AN INCREASED INTRA-PERITONEAL VOLUME EVENT WAS IDENTIFIED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE ONE OR MORE CYCLES ADVANCED TO 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 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 22:24:27. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 1539ML, INDICATING THE HOME PATIENT (HP) DRAINED 1539ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2300ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343883 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR