BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1961546 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00627
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 6, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    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). A LOG REVIEW REVEALED AN INSTANCE OF INCREASED INTRAPERITONEAL VOLUME (IIPV). THE PROBABLE CAUSE WAS DETERMINED TO BE INSUFFICIENT DRAIN, USE ERROR - TIDAL ULTRAFILTRATION (UF) REMOVAL SET TOO LOW. REVIEW OF THE SERVICE DATES AND ACTIVITIES REVEALED THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR THE REPORTED PROBLEM OF IIPV. A LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE MACHINE, A BAXTER TECHNICIAN FOUND AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 4. THE DRAIN VOLUME WAS 3292 ML. THIS EVENT MEETS OVERFILL CRITERIA. THIS IS REPORT 1 OF 2.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR