BEUDAMED
    FDA Adverse Event Other Summary report: N

    FREEDOM CYCLER

    MDR report key: 2928082 · Received January 16, 2013

    Report

    Report Number
    2937457-2013-00004
    Event Type
    Other
    Date Received
    January 16, 2013
    Date of Event
    December 23, 2012
    Report Date
    December 23, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE - NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K895336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDICAL REVIEW OF THE INFORMATION AND THE TREATMENT DATA OBTAINED WAS PERFORMED. A LARGE INTRA-PERITONEAL VOLUME DRAIN WAS REPORTED AFTER FILL 1 AND FILL 3. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS LARGE DRAIN VOLUME. THE DEVICE WILL BE INVESTIGATED UPON ITS RETURN TO THE MANUFACTURER AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    PT'S MOTHER STATED THE FREEDOM CYCLER WAS USED PRIOR WITHOUT PROBLEM. THE CYCLER WAS SET UP WITH NO ALARMS USING STANDARD TUBING AND THREE 1 LITER BAGS. THEN THE CCPD TREATMENT WAS STARTED. AFTER FILL 1: 120 ML, PT BECAME "MORE THAN FUSSY, WAS IN PAIN, COLOR WAS RED, AND BELLY WAS DISTENDED AND BIG." DWELL WAS BYPASSED AND DRAIN1: 220-230 ML. THE PT'S MOTHER REPORTED THE PT IMMEDIATELY BECAME COMFORTABLE AND LOOKED BETTER. MOTHER CONTINUED THE TREATMENT. FILL 2: 110 ML, DRAIN 2: 140 ML. FILL 3: 110 ML, PT BECAME SYMPTOMATIC AND DWELL WAS BYPASSED TO DRAIN 3: 210 ML. TREATMENT WAS STOPPED ON CYCLER AND MOTHER CONTINUED WITH MANUAL EXCHANGES. THE REMAINING FLUID IN THE SOLUTION BAGS WERE NOT WEIGHED AND THE PT'S MOTHER STATED A LOT MORE FLUID WAS GONE FORM THE FLUID BAG THAN EXPECTED. NO ALARMS OCCURRED. THE PT DID NOT HAVE A SERIOUS INJURY AND THE PT DID NOT REQUIRE MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24626 FREEDOM CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE - NORTH AMERICA FC

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO