BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3024080 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07501
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION OF THE DEVICE WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) FOUND IN THE DEVICE LOGS. THE IIPV WAS CONFIRMED BY REVIEW OF THE LOGS. THE 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    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 2333 ML, INDICATING THE HOME PATIENT (HP) DRAINED 2333 ML MORE THAN THE LARGEST PRESCRIBED FILL VOLUME OF 2200 ML. THIS MEANT THE TOTAL DRAIN VOLUME WAS APPROXIMATELY 4533 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
    126581 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE