BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 1672738 · Received April 29, 2010

    Report

    Report Number
    2937457-2010-00005
    Event Type
    Other
    Date Received
    April 29, 2010
    Date of Event
    March 31, 2010
    Report Date
    March 31, 2010
    Manufacturer
    FRESENIUS MEDICAL CARE - NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - CYCLER ADVANCED FROM DRAIN 0 TO FILL 1 AFTER 3 MINUTES. THE CYCLER MONITORS THE AMOUNT OF SOLUTION DELIVERED TO OR DRAINED FROM THE PT DURING TREATMENT. MANUAL EXCHANGES COULD NOT BE MONITORED BY THE CYCLER. IF THE LAST FILL PROGRAMMED WAS 0, THE CYCLER WILL ADVANCE FROM DRAIN 0 TO FILL 1 WHEN THE FLOW OF SOLUTION STOPS SINCE NO SOLUTION IS EXPECTED TO BE IN THE PERITONEAL CAVITY WHEN TREATMENT IS STARTED. THE OVERFILL OCCURRED IN THIS EVENT BECAUSE THE PT PERFORMED A MANUAL FILL DURING THE DAY WITH NO LAST FILL PROGRAMMED. (B)(4).

    Description of Event or Problem · 1

    A HOME PERITONEAL DIALYSIS PT'S WIFE REPORTED THAT THE CYCLER SKIPPED THE DRAIN 0 CYCLE. THE RECORDS SHOWED THAT THE PT DRAINED A TOTAL 358 ML. IN 3 MINUTES IN DRAIN 0 BEFORE SWITCHING TO FILL 1. THE PT C/O DIFFICULTY BREATHING, BECAME VERY LIGHT-HEADED AND THOUGHT HE WAS GOING TO PASS OUT. THE WIFE REALIZED THAT THE PT HAD NOT FULLY DRAINED THE SOLUTION THAT THE PT WAS FILLED MANUALLY DURING THE DAY, WHEN THE CYCLER SWITCHED TO THE NEXT FILL. SHE DRAINED HIM MANUALLY AND WAS ABLE TO DRAIN 3,500 ML IN THE FIRST DRAIN BAG AND 2,200 ML IN THE SECOND BAG. THE PT FELT BETTER AFTER DRAINING WITH THE FIRST BAG. THE PT'S PRESCRIPTION IS FOR FILL VOLUMES OF 2,500 ML. WITH NO LAST FILL. THE PT IS EMPTY WHEN HE DISCONNECTS FROM THE CYCLER IN THE MORNING. HE PERFORMS A MANUAL FILL OF 2,500 ML. DURING THE DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR