BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2080429 · Received May 6, 2011

    Report

    Report Number
    1423500-2011-05604
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    January 22, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE LOGS REVEALED ONE DRAIN VOLUME THAT MEETS THE IIPV (INCREASED INTRA-PERITONEAL VOLUME) CRITERIA. WITH REFERENCE TO THE IIPV DECISION TREE, THE ROOT CAUSE FOR THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN - ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD AND INSUFFICIENT DRAIN - USE ERROR, INAPPROPRIATE BYPASS OF INITIAL DRAIN. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPV. THE DEVICE MET SPECIFICATIONS WITH REGARDS TO THE IIPV. A LABELING REVIEW FOUND THE HOME CHOICE USER MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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 RTB-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOME PATIENT IS NO LONGER ON PERITONEAL DIALYSIS AS THEY HAVE TRANSFERRED TO HEMO DIALYSIS. 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

    AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE (HC) DEVICE. THE IIPV OCCURRED ON (B)(6) 2011 DURING DRAIN CYCLE 3. THE PROGRAMMED FILL VOLUME WAS 2700ML. THE DRAIN VOLUME WAS 4381ML. THIS VOLUME MEETS BAXTER'S IIPV CRITERIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR