BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER

    MDR report key: 3243232 · Received July 19, 2013

    Report

    Report Number
    2937457-2013-00096
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, MEDICAL RECORDS AND TREATMENT DATA HAVE BEEN REQUESTED, A LARGE INTRA-PERITONEAL VOLUME OF 3,094 NK WAS RECORDED TO HAVE BEEN LEFT IN THE PT'S ABDOMEN WITH AN UNK CAUSE. THE DEVICE IS CURRENTLY UNDERGOING EVAL AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    THE PT'S CAREGIVER CALLED TECH SUPPORT CONCERNING M22 SAFETY CLAMP ERROR IN THE FLUSHING STEP OF SETUP. THE CARETAKER REPORTED THE PT RETAINED FLUID IN THE ABDOMEN FOR AN UNK REASON. THE PT'S CAREGIVER STATED SHE WAS GOING TO TAKE HIM TO THE ER FOR EVAL. TREATMENT DATA FROM CYCLER: DRAIN 0.3 M. FILL 1: 2802 ML, DRAIN 1:2321 ML; FILL 2: 2802 ML, DRAIN 2: 2991 ML; FILL 3: 2802 ML, DRAIN 3: 1 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338986 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LIBERTY CYCLER TUBING