BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1823087 · Received September 1, 2010

    Report

    Report Number
    1423500-2010-03080
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 9, 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 RITE (RETURN INSTRUMENT TEST/EVALUATION) TEST WAS PERFORMED WHEN THE DEVICE WAS RETURNED TO THE BAXTER TAMPA BAY FACILITY FOR EVALUATION. THE DEVICE PASSED THE HOMECHOICE RITE FUNCTIONAL TEST AND THE HOMECHOICE RITE ELECTRICAL TEST. THE CAUSE OF THE IIPV WAS INSUFFICIENT DRAIN TIDAL ULTRAFILTRATION SET TOO LOW. THE DEVICE HAS BEEN ROUTED TO SERVICE. 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). DEVICE EVALUATION EXPECTED, BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP MDR.

    Description of Event or Problem · 1

    FIVE INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATIONS WERE IDENTIFIED IN THE LOG OF A HOMECHOICE (HC) DEVICE. THIS IS REPORT 1 OF 5. DURING INITIAL ASSESSMENT OF A HOMECHOICE DEVICE, AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WAS IDENTIFIED WHICH OCCURRED ON DATE (B)(6) 2010 DURING DRAIN CYCLE 5. THE DRAIN VOLUME WAS 4779 ML. THE PROGRAMMED FILL VOLUME WAS 2000 ML. THIS EVENT MEETS OVERFILL CRITERIA. ON (B)(6) 2010, PRODUCT SURVEILLANCE FOLLOWED UP WITH THE PATIENT'S NURSE. THE NURSE STATED THAT HE RECENTLY SPOKE WITH THE PATIENT AND THEY WERE DOING WELL ON THE NEW CYCLER WITH NO REPORTED ISSUES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 35 YR