BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 3161891 · Received June 6, 2013

    Report

    Report Number
    2937457-2013-00071
    Event Type
    Other
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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. A SUPPLEMENTAL INVESTIGATION WILL BE SUBMITTED WHEN THE PERITONEAL CYCLER (PLANT INVESTIGATION) IS COMPLETE.

    Description of Event or Problem · 1

    THE PT CALLED TECH SUPPORT WHILE IN STAT DRAIN AND STATED HE WAS FEELING UNCOMFORTABLE. PT STATED HE NEVER DOES A DAYTIME EXCHANGE. TREATMENT DATA FROM CYCLER: DRAIN 0: 1,571ML. FILL 1: 2533 ML. DRAIN 1: 11,084ML. THE PDRN STATED THAT AN INTERNAL ERROR MUST HAVE OCCURRED ON THE MACHINE BECAUSE THE PT DID NOT DRAIN THE AMOUNT RECORDED IN THE TREATMENT SHEET. AFTER THE FIRST DRAIN, THE PT REVERED TO ALTERNATE TREATMENT WHICH THE PT COMPLETED FOR THREE DAYS IN A ROW WITHOUT PROBLEMS. SHE SAID THE PT IS FINE, HAD NO SYMPTOMS, NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED AFTER THE EVENT. THE PT FINISHED THIS TREATMENT WITH MANUAL EXCHANGE. THE REPORTED LARGE DRAIN IS 403% OF THE PRESCRIBED FILL VOLUME OF 2750ML WHICH EXCEEDS THE 180% DRAIN CRITERIA FOR A REPORTABLE DEVICE MALFUNCTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251149 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE LIBERTY

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER SET| DELFLEX SOLUTION