BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2983509 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04958
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE IIPV WAS CONFIRMED BY REVIEW OF THE LOGS. THE ASSIGNABLE CAUSE OF THE IIPV WAS DETERMINED TO BE ONE OR MORE CYCLES ADVANCED TO NEXT FILL WHEN SLOW/NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE LOGS OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED DURING DRAIN CYCLE 4. THE PATIENT'S ULTRAFILTRATION (UF) READING WAS 2475 ML, INDICATING THE HOME PATIENT (HP) DRAINED 2475 ML MORE THAN THE LARGEST PRESCRIBED FILL VOLUME OF 3000 ML. THIS MEANT THE TOTAL DRAIN VOLUME WAS APPROXIMATELY 5475 ML, WHICH MEETS THE IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86913 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR