BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 2851060 · Received November 19, 2012

    Report

    Report Number
    2937457-2012-00045
    Event Type
    Other
    Date Received
    November 19, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 22, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDICAL RECORD REVIEW WAS PERFORMED ON THE PATIENT'S TREATMENT DATA AND MEDICAL INFORMATION OBTAINED. A LARGE DRAIN VOLUME WAS REPORTED AFTER DURING DRAIN 4. PER PD NURSES, THE PATIENT HAD NO SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED LARGE DRAIN. THE DEVICE IS CURRENTLY UNDERGOING AN EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    THE PREVIOUS CCPD TREATMENT ENDED ON A DRAIN WITH A POSITIVE UF. PATIENT DID NOT DO A MANUAL EXCHANGE DURING THE DAY. THEN PATIENT'S NEPHROLOGIST INCREASED PATIENT'S FILL VOLUME PRESCRIPTION FOR THE COPD TREATMENTS. DURING PATIENT'S FIRST TREATMENT WITH NEW PRESCRIPTION, PATIENT STATED WAKING UP FEELING FULL, PAIN IN STOMACH AND COULD NOT SIT UP. PATIENT THEN DID A STAT DRAIN. PER TREATMENT DATA FROM THE CYCLER, IN FILL 4 PATIENT FILLED WITH 2407 ML AND STAT DRAIN 4554 ML. PATIENT WAS ABLE TO CONTINUE AND COMPLETE THE TREATMENT. PATIENT STATED FEELING BETTER AFTER THE DRAIN. TREATMENT DATA FROM EVENT. DRAIN 0:229 ML, FILL 1:2516 ML, DRAIN: 2614 ML, FILL 2:2407 ML, DRAIN 2: 2605 ML, FILL 3: 2397 ML, DRAIN 3: 2592 ML, FILL 4: 2407 ML, IN DWELL 4, PATIENT DID A STAT DRAIN 4: 4554 ML, FILL 5: 2496 ML, DRAIN 5: 2604 ML, FILL 6: 2407 ML, DRAIN 6 3127 ML.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR