BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO V

    MDR report key: 20948086 · Received December 16, 2024

    Report

    Report Number
    2015691-2024-09644
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 25, 2024
    Report Date
    March 27, 2025
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE COMPLAINT WAS UNABLE TO BE CONFIRMED SINCE THE COMPLAINT AFFECTED UNIT WAS NOT RETURNED FOR EVALUATION, NEITHER AN IMAGE OR VIDEO OF CONFIRMED DEVICE DEFICIENCY WERE PROVIDED; THEREFORE, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE COULD NOT BE CONFIRMED. NO ROOT CAUSE COULD BE IDENTIFIED SINCE NO PRODUCT SAMPLE NOR OBJECTIVE EVIDENCE WAS PROVIDED FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES FOR THE DEVICE INCLUDE: DYG: CATHETER, FLOW DIRECTED, KRA: CATHETER, CONTINUOUS FLUSH, DQE: CATHETER, OXIMETER, FIBEROPTIC, DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC. NO PRODUCT WILL BE RETURNED FOR EVALUATION; IT WAS DISCARDED. WITHOUT 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. HOWEVER, AN INVESTIGATION WILL BE INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE LOT NUMBER. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS, 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 AFTER INSERTION OF THE 777F8 CATHETER, IT WILL NOT SUPPLY A CARDIAC OUTPUT OR CARDIAC INDEX. IN ADDITION, THE TEMPERATURE FLUCTUATES WILDLY. THE CATHETER CHECKED OUT OK PRIOR TO INSERTING IT INTO THE PATIENT. ONCE PLACED INTO THE PATIENT, IT WAS FIRST NOTICED THAT THE TEMPERATURE FLUCTUATED WILDLY FROM 32 DEGREES TO OVER 39.5 DEGREES CELSIUS. THEN NO CO OR CI WOULD INITIATE. THEY ATTEMPTED TO REPOSITION THE CATHETER, SAME RESULT. THEN THE STAFF TRIED A DIFFERENT SET OF CABLES FIRST THEN A WHOLE NEW HEMOSPHERE, THE SAME ISSUE OCCURRED. THE MONITOR USED WAS THE EDWARDS HEMOSPHERE. SOFTWARE VERSION 2.0. WE USE ARROW 9FR DOUBLE LUMEN CATHETERS AS WE HAVE HAD FOR SOME TIME. NO INJURY WAS DONE TO THE PATIENT BUT WITHOUT THE CO/CI IT MADE CARE MORE DIFFICULT INTRAOPERATIVE AND POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291258 SWAN-GANZ CCOMBO V CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 777F8 65780873

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown