BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 2982553 · Received February 21, 2013

    Report

    Report Number
    2937457-2013-00010
    Event Type
    Other
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    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 SHEETS AND MEDICAL INFORMATION PROVIDED. A LARGE INTRA-PERITONEAL VOLUME DRAINED AT DRAIN 2. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORTED LARGE DRAIN VOLUME. THE DEVICE IS CURRENTLY UNDERGOING EVALUATION.

    Description of Event or Problem · 1

    PATIENT CALLED TECH SUPPORT DUE TO AN "AIR DETECTED IN CASSETTE" ALARM DURING DRAIN 2 OF THE CCPD TREATMENT. PATIENT STATED HE DID NOT SEE AIR LINE THE LINES. TREATMENT DATA OBTAINED FROM THE CYCLER: DRAIN 0: 1662 ML. FILL 1: 2506 ML, DRAIN 1: 2787 ML. FILL 2: 2503 ML, DRAIN 2: 8016 ML THEN TREATMENT WAS STOPPED. PATIENT DENIED HAVING DISCOMFORT. PATIENT REPORTS THE HEATER BAG STILL HAS SOLUTION BUT NO INFORMATION OF VOLUME REMAINING IN THE HEATER BAG OR SUPPLY BAGS. PATIENT'S PD NURSE REPORTED THE PATIENT HAD NO ISSUES OR PROBLEMS AS A RESULT AND DID NOT REQUIRE MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75335 LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR