BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1953295 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00300
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 2, 2010
    Report Date
    December 15, 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).REVIEW OF THE DEVICE LOGS CONFIRMED THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. EXTERNAL & INTERNAL VISUAL INSPECTIONS REVEALED NO PROBLEMS. THE CAUSE OF THE IIPV WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO ONE OR MORE CYCLE ADVANCING TO THE NEXT FILL WHEN SLOW/NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. A SERVICE HISTORY REVIEW (SHR) REVEALED THAT NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE IIPV. THE DEVICE WAS DETERMINED TO MEET THE SPECIFICATION REQUIREMENTS RELATIVE TO THE IIPV IDENTIFIED VIA DEVICE LOG REVIEW. 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). TWO OF 3 EMDRS.THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED ON (B)(6) 2010 DURING DRAIN CYCLE 2. THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 490 ML AND THE DRAIN VOLUME WAS 1042 ML, WHICH MET IIPV CRITERIA. 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 27 YR