BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2222774 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11233
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    September 28, 2009
    Report Date
    August 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS OWNED BY A CLINICAL EDUCATOR AND WAS HER TRAINING DEVICE, AND HAD NEVER BEEN USED ON A PATIENT. THE IIPV EVENT WAS A TRAINING SESSION WITH A DUMMY TUMMY AND NOT AN ACTUAL IIPV. BASED ON INFORMATION PROVIDED BY THE CLINICAL EDUCATOR THERE WAS NO MALFUNCTION OF THE DEVICE THAT COULD HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY WERE IT TO RECUR.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE MACHINE, A BAXTER TECHNICIAN FOUND AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) THAT WAS IDENTIFIED IN PATIENT THERAPY LOG. THE ULTRAFILTRATION WAS 585 ML DURING CYCLE 2, MEANING THE PATIENT DRAINED 585ML MORE THAN THE FILL VOLUME OF 500 ML. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED. THIS EVENT MEETS OVERFILL CRITERIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1