BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 2823636 · Received November 1, 2012

    Report

    Report Number
    2937457-2012-00039
    Event Type
    Other
    Date Received
    November 1, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 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 SHEETS. THIS IS A REPORTABLE EVENT FOR A POTENTIAL IIPV BASED ON THE PATIENT'S SYMPTOMS AND REPORT OF THE HEATER BAG BEING EMPTY. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS INCREASED VOLUME. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    PATIENT SET UP THE CYCLER FOR A CCPD TREATMENT WITH ONE 5 LITER (HEATER BAG) AND ONE 2 LITER (SUPPLY BAG). PATIENT STATED SHE CONNECTED TO THE CYCLER AND WATCHED DRAIN 0 THRU FILL 1. TREATMENT DATE FROM THE CYCLER: DRAIN 0: 1,435 ML, UF: 433ML. FILL 1: 1,196ML, DRAIN 1: 1,220 ML, UF: 24ML. FILL 2: 1,081ML, DRAIN 2: 1,232 ML, UF: 151ML. FILL 3: 1081ML, TREATMENT STOPPED. PATIENT THEN REMEMBERS WAKING UP TO ALARMS: REMOVE EXCESS WEIGHT FROM HEATER, CHECK PATIENT LINE. PATIENT STATED THE CYCLER WAS PUMPING BUT NOT REGISTERING THE AMOUNT AND THE HEATER BAG WAS "ALMOST EMPTY." PATIENT STATED HER STOMACH WAS LIKE A BALLOON AND FELT FULL. PATIENT THEN DID A MANUAL EXCHANGE. STATED SHE DID NOT DRAIN COMPLETELY, DRAINING ONLY 1200 ML UNTIL SHE FELT COMFORTABLE. PATIENT SYMPTOMS RESOLVED. THE NEXT DAY, PATIENT REPORTED DOING A MID DAY EXCHANGE AT 12 NOON, DRAINING 1300 AND FILLING WITH 1100 ML. PER PD NURSE, PATIENT HAD NO ADVERSE EFFECTS AS A RESULT.

    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 72 YR