BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    MDR report key: 21096650 · Received January 7, 2025

    Report

    Report Number
    2015691-2025-00122
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Report Date
    February 26, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    UDI-DI
    00690103197587
    PMA / PMN Number
    K053609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AND NOT RETURNED FOR PRODUCT EVALUATION. WITHOUT ITS RETURN, IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS DAMAGE OR A DEFECT THAT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS THE COMPLAINT COULD NOT BE CONFIRMED, THERE IS NOT SUFFICIENT EVIDENCE TO DETERMINE A ROOT CAUSE. AS PART OF THE MANUFACTURING PROCESS 100 PERCENT OF THE UNITS GO THROUGH A CATHETER FLOW INSPECTION PROCESS. 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

    THE PRODUCT HAS BEEN REQUESTED FOR RETURN FOR A PRODUCT EVALUATION. IT HAS NOT ARRIVED. ONCE THE PRODUCT EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE FINDINGS. THE LOT NUMBER IS UNKNOWN. THEREFORE, THE DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. ADDITIONAL PRODUCT CODES, DRE AND DQE. ADDITIONAL 510K NUMBER K110167.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE OXIMETRY CENTRAL VENOUS CATHETER, DURING USE. THE CATHETER BODY BECAME KINKED NEAR THE DISTAL END OF THE BACKFORM. AS A RESULT, THE CATECHOLAMINE MEDICATION WAS NOT INFUSED CONTINUOUSLY INTO THE PATIENT. THE MEDICATION BECAME STUCK AT THE KINKED PORTION OF THE CATHETER. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236646 EDWARDS OXIMETRY CENTRAL VENOUS CATHETER EDWARDS OXIMETRY CENTRAL VENOUS CATHETER DXG EDWARDS LIFESCIENCES X3820SJD 00690103197587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown