BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 3101871 · Received May 3, 2013

    Report

    Report Number
    2937457-2013-00054
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 7, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT HAS REPORTED AN OVERFILL GREATER THAN 200%. THE LARGE DRAIN VOLUME OF 7407ML CANNOT BE EXPLAINED. THE CYCLER HAS NOT BEEN RETURNED T THE MFR FOR EVAL. A SUPPLEMENTAL MDR REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT CALLED TECH SUPPORT STATING THAT THERE WAS A "SUPPLY LINES BLOCKED" MESSAGE IN DWELL 3 OF 4. PT ADDED THAT THE SUPPLY BAG WAS COMPLETELY EMPTY AND THE HEATER BAG HAD SOME SOLUTION IN IT. THERE WERE NO IDENTIFIABLE LEAKS OR OTHER REASONS FOR THERE TO BE A LOSS OF SOLUTION. A CHECK OF THE TREATMENT DATA SHOWED THAT THE PT FILLED WITH 2298ML IN FILL 1 AND THEN DRAINED 7407ML IN DRAIN 1. PT DOES NOT KNOW WHERE THE EXCESS FLUID CAME FROM. DURING THE TECH SUPPORT CALL, THE PT VOICED NO CONCERNS OF DISCOMFORT AND CLAIMS TO HAVE NOT NOTICED THE EXCESS FLUID FROM THE DRAIN. DRAIN 0: 634; FILL 1: 2298, DRAIN 1: 7407; FILL 2: 2180, DRAIN 2: 2812; FILL 3: 2224, DRAIN 3 -. PT'S PD RN WAS CONTACTED REGARDING ADDITIONAL EVENT INFORMATION. THE RN STATED THAT THE PT DID NOT REPORT THIS EVENT TO HER AND THAT THE LIKELIHOOD OF A DRAIN THIS LARGE WOULD BE IMPOSSIBLE. THE RN MENTIONED THAT THE PT IS A SMALL MAN WEIGHING APPROX (B)(6) AND WOULD BE IN A GREAT DEAL OF PAIN IF THIS WERE TO HAVE OCCURRED. THE RN ADDED THAT BOTH THE PT AND THE PT'S WIFE ARE VERY DILIGENT IN REPORTING PROBLEMS WITH CCPD TO HER. AS OF THIS DATE, THE PT CONTINUES WITH THE CYCLER. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION OF ANY TYPE DURING OR FOLLOWING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195341 LIBERTY CYCLER FKX22 FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER SET| DEFLEX PD SOLUTION