BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 2640462 · Received June 27, 2012

    Report

    Report Number
    2937457-2012-00024
    Event Type
    Other
    Date Received
    June 27, 2012
    Date of Event
    May 29, 2012
    Report Date
    May 29, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION HAS STARTED BUT NOT YET COMPLETE. (B)(4).

    Description of Event or Problem · 1

    PT CALLED TECH SUPPORT STATING THAT SHE THINKS SHE HAD AN OVERFILL SITUATION LAST NIGHT DURING THE CCPD TREATMENT. PT DENIED ANY PROBLEMS WITH THE PREVIOUS TREATMENT WHICH ENDS WITH A LAST FILL OF 1999 ML. PT STATED SHE DID A MANUAL DRAIN DURING THE DAY AND WAS EMPTY AT THE TIME SHE CONNECTED TO THE CYCLER. A CCPD TREATMENT WAS STATED. DRAIN 0=0ML. FILL1 = 1999 ML. DRAIN 1 = 1850 ML. FILL2 = 1795 ML. AFTER THE FILL AND DURING THE DWELL, PT STATED FEELING FULL "LIKE I WS GOING TO BURST" WITH BACK PAIN AND TIGHTNESS. PT DID A STAT DRAIN OBTAINING 4566 ML. PT STATED FEELING GOOD AFTER DRAINING AND WAS ABLE TO COMPLETE THE TREATMENT. PT RECEIVED A REPLACEMENT CYCLER AND CONTINUES CCPD.

    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 UNK LIBERTY CYCLER TUBING SET| PD SOLUTIONS