BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN GANZ

    MDR report key: 21865893 · Received April 18, 2025

    Report

    Report Number
    2015691-2025-03018
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Report Date
    July 3, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQO
    UDI-DI
    00690103000405
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT YET ARRIVED. WHEN IT ARRIVES AND THE PRODUCT EVALUATION HAS BEEN COMPLETED, THE RESULTS WILL BE SENT IN A SUPPLEMENTAL SUBMISSION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. ADDITIONAL PRODUCT CODES, KRA, DYG, DQE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE FACILITY STATED IT IS UNAVAILABLE. WITHOUT THE RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. AS PART OF THE CATHETER MANUFACTURING PROCESS A 100% OF THE UNITS GO THROUGH AN ELECTRICAL INSPECTION. THE COMPLAINT AFFECTED UNIT WAS NOT RETURNED FOR EVALUATION, THEREFORE A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE ARE INACCURATE VALUES THAT OCCURRED DURING PATIENT USE WITH A SWAN GANZ TRUE SIZE CATHETER. THE VALUES RECEIVED AND THE VALUES EXPECTED WERE NOT GIVEN BY THE FACILITY. THE CABLES AND MODULES THAT WERE INVOLVED WERE EXCHANGED FOR DIFFERENT EQUIPMENT, BUT THAT DID NOT SOLVE THE ISSUE. INSTEAD, THE EV1000 FLOTRAC WAS EMPLOYED FOR HEMODYNAMIC MONITORING. THE FACILITY REPORTED THAT THIS OCCURRED IN THE LAST SEVERAL WEEKS, BUT WAS UNABLE TO GIVE AN EXACT DATE OF OCCURRENCE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THERE WAS NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763661 SWAN GANZ SWAN GANZ THERMODILUTION CATHETER DQO EDWARDS LIFESCIENCES 131F7 00690103000405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown