BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 2248200 · Received August 23, 2011

    Report

    Report Number
    2937457-2011-00014
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CYCLER PASSED THE SCALE CALIBRATION CHECK AND A VALVE ACTUATION TEST. THE WEIGHTED AND DISPLAYED FILL VOLUMES WERE WITHIN THE 2% TOLERANCE. THE REPORTED DC (DRAIN COMPLICATION), FC (FILL COMPLICATION) OR M65 (SCALE READING ERROR) WERE NOT DUPLICATED DURING SIMULATED TREATMENT. (B)(4). THE STN # K043363.

    Description of Event or Problem · 1

    PATIENT IS ON CCPD AND PATIENT'S WIFE REPORTED THAT THEY WERE UP ALL NIGHT WITH ALARMS. SHE SAID THAT THE CYCLER SHOWED THAT PATIENT DID NOT FILL ENOUGH BUT HE FELT FULL SO HE BYPASSED THE FILLS. TX SETTINGS ARE CYCLE BASED CCPD, 4 FILLS OF 2,000 ML., LAST FILL 0. TX DETAILS: FILL = 675, DRAIN = 3334; FILL = 1212, DRAIN = 4793; FILL = 683, DRAIN = 1055; FILL = 594, DRAIN = 4026. THE REMAINING SOLUTION FROM THE TWO 5-L BAGS USED WAS 3700 ML. INDICATING THAT TOTAL SOLUTION USED WAS ABOUT 6,300 ML. TOTAL FILL VOLUME RECORDED WAS 3164. TOTAL DRAIN VOLUME RECORDED WAS 13208.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR CASSETTE SET| PD SOLUTION