BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1911853 · Received December 1, 2010

    Report

    Report Number
    1423500-2010-06412
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    September 27, 2010
    Report Date
    November 8, 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
    SERVICE AND TESTING PERSONNEL

    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 RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE PAL EVALUATED THE DEVICE AND UPON FURTHER EVALUATION THIS EVENT WAS DETERMINED NOT TO MEET IIPV (INCREASED INTRAPERITONEAL VOLUME) CRITERIA. DRAIN VOLUME WAS 2301ML. THE HOME PATIENT THEN COMPLETED A LAST FILL OF 1500 ML BEFORE PERFORMING THE POST THERAPY DRAIN, REMOVING 310 ML. THE DRAIN VOLUME DOES NOT MEET THE CRITERIA FOR IIPV.

    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 AT 10:20: 42 WITH DRAIN VOLUME OF 2611 ML (COMBINED DRAIN VOLUME CYCLE 4: 2301 ML, AND POST THERAPY DRAIN VOLUME 310 ML). THIS EVENT MEETS OVERFILL CRITERIA.

    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