BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2970833 · Received February 20, 2013

    Report

    Report Number
    1416980-2013-04293
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: 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 A USE ERROR, AS THE TIDAL TOTAL ULTRA-FILTRATION (UF) REMOVAL WAS SET TOO LOW.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 108 ALARM WAS IDENTIFIED. THE ALARM OCCURRED DURING NIGHT DRAIN NUMBER EIGHT. THIS INFORMATION MEETS INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74307 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1