BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1911586 · Received December 1, 2010

    Report

    Report Number
    1423500-2010-06408
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 6, 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). PRODUCT SURVEILLANCE CONTACTED THE NURSE AND NOTIFIED THE NURSE OF THE INCIDENTS OF IIPV THAT WERE FOUND DURING THE DEVICE LOG REVIEW AND THE PROBABLE CAUSE THAT WAS IDENTIFIED. A REVIEW OF THE DEVICE LOGS CONFIRMED THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENTS. EXTERNAL & INTERNAL VISUAL INSPECTIONS REVEALED NO PROBLEMS. THE DEVICE WAS FOUND TO MEET THE SPECIFICATION REQUIREMENTS RELATIVE TO THE IIPV IDENTIFIED VIA DEVICE LOG REVIEW. THE CAUSE OF THE IIPV WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO ONE OR MORE CYCLES ADVANCING TO THE NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. A SERVICE HISTORY REVIEW REVEALED THAT NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE IIPV. 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).

    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.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE MACHINE, A BAXTER TECHNICIAN FOUND AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION IN THE EVENT LOGS WHICH OCCURRED ON (B)(6) 2010, STARTED AT 00:33 WITH ULTRAFILTRATION VOLUME OF 1440ML DURING CYCLE 3. THE 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