BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 3020626 · Received March 19, 2013

    Report

    Report Number
    2937457-2013-00030
    Event Type
    Other
    Date Received
    March 19, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 18, 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 REVIEW WAS PERFORMED ON THE INFO PROVIDED. A LARGE INTRA-PERITONEAL VOLUME DRAINED AT DRAIN 1 WITH AN UNDETERMINED CAUSE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORTED LARGE DRAIN VOLUME. THE DEVICE IS CURRENTLY UNDERGOING EVALUATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PT CALLED TECH SUPPORT REGARDING FILLING SLOW DURING A CCPD TREATMENT. PT REPORTED FEELING FULL AFTER THE FILL. PT PERFORMED A STAT DRAIN AND OBTAINED 4745 ML. TREATMENT PRESCRIPTION: 4 FILLS OF 2305 MIL AND NO LAST FILL. NO MID-DAY MANUAL EXCHANGES. TREATMENT DATA OBTAINED FROM THE PT: DRAIN 0: 188 ML. FILL 1: 2296 ML. NINE MINUTES INTO DWELL PATIENT DID A STAT DRAIN DUE TO FEELING FULL, BLOATED, SWOLLEN, AND HAD DIFFICULTY BREATHING. DRAIN 1: 4745 ML. PT CANCELLED THE TREATMENT. PT REPORTED FEELING BETTER AFTER DRAINING AND HAD NO ADVERSE EFFECTS AS A RESULT. PATIENT USES TWO 5 LITER PD SOLUTION BAGS FOR THE TREATMENT. PATIENT REPORTS THE HEATER BAG WAS EMPTY AND THE SUPPLY BAG HAD A LITTLE BIT OF FLUID. OF THE 4 DRAIN BAGS USED, ONE WAS EMPTY AND THE OTHER THREE WERE LESS THAN HALF FULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113418 LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER

    Patients

    Seq Age Sex Outcome Treatment
    1 PD CATHETER WITH EXTENSION SET| LIBERTY CYCLER TUBING SET| PD SOLUTION