BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    MDR report key: 21714638 · Received March 27, 2025

    Report

    Report Number
    2015691-2025-02330
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 6, 2025
    Report Date
    June 10, 2025
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQE
    UDI-DI
    00690103197433
    PMA / PMN Number
    K053609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED TRIPLE LUMEN OXIMETRY CATHETER. THE REPORTED EVENT OF OPTICAL FIBER OF THIS OXIMETRY CABLE WAS EXPOSED FROM THE CATHETER TIP WAS CONFIRMED. AS RECEIVED INTO LAB, BOTH OPTIC FIBERS WERE EXPOSED FROM CATHETER TIP. ADHESIVE WAS VISIBLE AROUND THE FIBER BOND SITE AT CATHETER TIP. EDGES OF EXPOSED FIBERS SHOWED SMOOTH SURFACE. OPTICAL MODULE CONNECTOR WAS OPENED FOR FURTHER EVALUATION, AND FIBERS INSIDE OPTICAL CONNECTOR WERE COILED AND NO VISIBLE INCONSISTENCY WAS OBSERVED INSIDE OPTICAL MODULE CONNECTOR. NO OTHER VISIBLE DAMAGE/INCONSISTENCY WAS OBSERVED FROM THE RETURNED CATHETER. ALL THRU-LUMENS WERE FOUND TO BE PATENT AND DID NOT LEAK. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT. AS PART OF THE MANUFACTURING PROCESS, A 100% OF THE UNITS GO THROUGH A TIP INSPECTION. DURING THIS PROCESS, THE TIP AREA IS INSPECTED FOR ADHESIVE AND CONTAMINATION, FIBER OR TIP DEFORMATION, ALIGNMENT BETWEEN DISTAL LUMEN AND FIBERS, AND EXPOSED FIBERS.

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. 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 A PART OF THE MONTHLY REVIEW. ADDITIONAL FDA PREMARKET SUBMISSION: K110167.

    Description of Event or Problem · 0

    AS REPORTED, DURING USE IN PATIENT, THE OPTICAL FIBER OF THIS OXIMETRY CABLE WAS EXPOSED FROM THE CATHETER TIP AS THE PATIENT REMOVED THE CATHETER BY THEMSELVES AT ICU. THE CATHETER WAS INSERTED INTO THE PATIENT DURING CARDIAC SURGERY. THE CUSTOMER TRIED TO CHECK IF THERE WAS ANY RESIDUALS IN THE PATIENT'S BODY WITH ECHO, BUT THEY WERE UNABLE TO IDENTIFY IF IT WAS FROM THE CATHETER OR PLAQUE. THE PATIENT IS BEING MONITORED AT ICU WITHOUT ANOTHER OXIMETRY CATHETER BEING INSERTED. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2415727 EDWARDS OXIMETRY CENTRAL VENOUS CATHETER CATHETER, OXIMETER, FIBEROPTIC DQE EDWARDS LIFESCIENCES PR X3820SJD 00690103197433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown