BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 1982817 · Received February 9, 2011

    Report

    Report Number
    2015691-2011-14757
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K934742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS STATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE THE DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED WITH THE DATA FROM THE (B)(6) DATA LOGGERS. ANALYSIS OF THE DATA FOUND THAT DUE TO THE SIGNAL TO NOISE RATIO (SNR), IT TAKES MORE TIME (20+ MINUTES) FOR THE CCO VALUES TO AVERAGE. WHEN ICO IS PERFORMED SHORTLY AFTER START UP, THE CCO VALUES ARE INITIALLY LOW. IF THE USER REACTS TO THIS INITIAL VALUE AND DISREGARDS CCO FOR THE DURATION OF THE CASE, THEY WILL NOT SEE THAT IT TRENDS UP TO AN EXPECTED VALUE AFTER AVERAGING. THE INVESTIGATION RESULTS WERE SHARED WITH THE CUSTOMER DURING AN ON-SITE VISIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STAFF WAS EXPERIENCING CHALLENGES WITH THE SURFACE TEMPERATURE AND THE CONTINUOUS CARDIAC OUTPUT PARAMETERS GIVEN BY THE CATHETER. IT WAS FURTHER INDICATED THAT THE CARDIAC INDEX (CI) MEASUREMENTS WERE NOT MATCHING UP WITH THE PATIENT'S CLINICAL STATUS. IT WAS INDICATED THAT THERE WERE SEVERAL POSSIBILITIES ADDRESSED WITH THE STAFF ON WHY THESE EVENTS COULD BE OCCURRING. IT WAS STATED THAT THERE APPEARED TO BE ERRONEOUS VALUES ON THE MONITOR. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD CONTINUOUS CARDIAC OUTPUT CATHETER DYG EDWARDS LIFESCIENCES, PR 746HF8

    Patients

    Seq Age Sex Outcome Treatment
    1