BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    MDR report key: 23881651 · Received December 23, 2025

    Report

    Report Number
    2015691-2025-10523
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 3, 2025
    Report Date
    January 28, 2026
    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

    ADDITIONAL PRODUCT CODES INCLUDE: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION. DXG COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION. 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. THE DEVICE HISTORY RECORD REVIEW HAS NOT YET BEEN 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 Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR PRODUCT EVALUATION. WITHOUT RETURN OF THE UNIT, 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 OR IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT NONCONFORMANCES. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS GO THROUGH OPTICAL INSPECTION AND A DRY LEAK TEST. THIS DRY LEAK TEST IS PERFORMED AFTER THE BACKFORMING PROCESS AND IN THE SUB ASSEMBLY MANUFACTURING PROCESS AS WELL. 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.

    Description of Event or Problem · 0

    AS REPORTED DURING USE IN A PATIENT THIS OXIMETRY CATHETER HAD LEAKAGE FROM THE OPTICAL MODULE CONNECTOR. THE LEAKED SOLUTION WAS TRANSPARENT AND COULD BE SALINE, BUT IT WAS UNABLE TO BE CONFIRMED. NO ADDITIONAL TREATMENT WAS REQUIRED DUE TO THIS EVENT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442685 EDWARDS OXIMETRY CENTRAL VENOUS CATHETER CATHETER, OXIMETER, FIBEROPTIC DQE EDWARDS LIFESCIENCES PR X3820SJD 66619369 00690103197433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown