BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    MDR report key: 23407847 · Received October 28, 2025

    Report

    Report Number
    2015691-2025-08871
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 3, 2025
    Report Date
    December 23, 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

    ADDITIONAL FDA PRODUCT CODES INCLUDE: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION. DXG COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS NO LOT NUMBER WAS PROVIDED. 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

    ONE OXIMETRY CATHETER WAS RETURNED FOR EVALUATION. CUSTOMER REPORT OF LEAKAGE ISSUE WAS CONFIRMED. BLOOD WAS VISIBLE AT THE OPTICAL MODULE CONNECTOR AS RECEIVED. LEAKAGE WAS DETECTED BETWEEN THE PROXIMAL LUMEN AND OPTICAL FIBER LUMEN INSIDE BACKFORM. NO LEAKAGE OR OCCLUSION WAS OBSERVED IN DISTAL AND MEDIAL LUMENS. NO OTHER VISIBLE DAMAGE/INCONSISTENCY WAS OBSERVED FROM THE RETURNED CATHETER. A CUT DOWN OF THE BACKFORM WAS PERFORMED FOR FURTHER EVALUATION, AND A CRACK OF 4 MM WAS OBSERVED INSIDE THE BACKFORM BETWEEN THE PROXIMAL LUMEN AND OPTICAL FIBER LUMEN THAT COULD LEAD TO INTERNAL LEAKAGE (SEE ATTACHED PHOTO). THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS A LOT NUMBER WAS NOT PROVIDED. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS GO THROUGH 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. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING OR DESIGN DEFECT. THEREFORE A ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    AS REPORTED AFTER SURGERY AND RETURNING FROM THE ICU DURING USE IN PATIENT THIS OXIMETRY CATHETER HAD MEDICATION LEAKAGE FROM THE OPTICAL MODULE CONNECTOR. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. NO FURTHER INFORMATION INCLUDING THE NAME OF LEAKED MEDICATION WAS AVAILABLE. 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
    19500 EDWARDS OXIMETRY CENTRAL VENOUS CATHETER CATHETER, OXIMETER, FIBEROPTIC DQE EDWARDS LIFESCIENCES PR X3820SJD 00690103197433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown