BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1901268 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05860
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 25, 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 DEVICE WAS RECEIVED AND EVALUATED. A REVIEW OF THE DEVICE LOGS REVEALED AN INCREASED INTRAPERITONEAL VOLUME (IIPV). THE ASSIGNABLE CAUSE OF THE IIPV 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. A SERVICE HISTORY REVIEW WAS PERFORMED. NO ISSUES WERE IDENTIFIED 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 WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 12. THE ULTRAFILTRATION VOLUME WAS 65 ML (MILLILITERS). THE PROGRAMMED FILL VOLUME WAS 200 ML. THIS EVENT MEETS OVERFILL CRITERIA. THIS IS REPORT 7 OF 7. ON (B)(6) 2010, PRODUCT SURVEILLANCE FOLLOWED UP WITH THE NURSE, AND PROVIDED THE RESULTS OF EVALUATION. THE NURSE STATED THAT THE DEVICE WAS USED WHILE THE PATIENT WAS IN THE HOSPITAL. THIS IS NOT THE PATIENT'S CLINIC AND NO ADDITIONAL INFORMATION WAS OBTAINED FROM THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1