BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 3030355 · Received March 27, 2013

    Report

    Report Number
    2937457-2013-00040
    Event Type
    Other
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDICAL REVIEW WAS PERFORMED ON THE INFORMATION PROVIDED. A LARGE INTRA-PERITONEAL VOLUME DRAINED AT DRAIN 1 AND 2 WITH AN UNDETERMINED CAUSE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORTED LARGE DRAIN VOLUME. THE DEVICE IS CURRENTLY UNDERGOING EVALUATION AND SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PERITONEAL DIALYSIS (PD) NURSE CALLED TECH SUPPORT TO REPORT NUMEROUS ALARMS, HIGH DRAIN VOLUMES, AND PATIENT BEING SHORT OF BREATH DURING A CCPD TREATMENT ON THE LIBERTY CYCLER. THE PREVIOUS TREATMENT ENDED WITH A TOTAL UF OF 3053 ML AND LAST FILL OF 2000 ML. PATIENT DID NOT PERFORM A MANUAL EXCHANGE PRIOR TO CONNECTING FOR THE NEXT TREATMENT. ON (B)(6) 2013 THE CYCLER IS SET UP WITH FOUR BAGS OF 5 LITER SOLUTIONS. DRAIN 0:930 ML. FILL 1: 1,386 ML, DRAIN 1: 4595 ML. FILL 2: 1,829 ML, DRAIN 2: 5194 ML. TREATMENT WAS CANCELED. ALARMS: HEATER BAG, FILL COMPLICATIONS, AND SCALE READING ERROR DURING FILL 1 AND 2. NURSE STATED THE PATIENT WAS FEELING SHORT OF BREATH BUT BETTER AFTER DRAINING. THE HEATER BAG WAS REPORTED TO HAVE SOME SOLUTION IN IT AND THREE SUPPLY BAGS AREA STILL FULL. PATIENT'S TREATMENT PRESCRIPTION: 5 FILLS OF 2500 ML AND A LAST FILL OF 2000 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125453 LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PD SOLUTIONS| LIBERTY CYCLER TUBING SET| PD CATHETER WITH EXTENSION SET