BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

    MDR report key: 21096653 · Received January 7, 2025

    Report

    Report Number
    2015691-2025-00123
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Report Date
    April 1, 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 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND A PRODUCT EVALUATION WAS PERFORMED. THE FINDINGS FOUND THAT THE REPORT OF LEAKAGE WAS CONFIRMED. THERE WAS BLOOD VISIBLE AT THE OPTICAL MODULE CONNECTOR. THE LEAKAGE WAS DETECTED BETWEEN THE DISTAL LUMEN AND THE OPTICAL FIBER LUMEN INSIDE THE BACKFORM. THERE WAS NO LEAKAGE OR OCCLUSION OBSERVED IN THE PROXIMAL AND MEDIAL LUMENS. A VISUAL INSPECTION FOUND NO OTHER DAMAGE OR INCONSISTENCY FROM THE CATHETER, INCLUDING AT THE TIP. THE BACKFORM WAS CUT DOWN AND A GAP WAS OBSERVED INSIDE THE BACKFORM BETWEEN THE DISTAL LUMEN AND OPTICAL FIBER LUMEN. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. CORRECTIVE ACTION WAS GENERATED TO INVESTIGATE LEAKAGE IN THE BACKFORM. THERE ARE PROCESS CONTROLS IN PLACE TO DETECT THE REPORTED CONDITION. 100 PERCENT TESTS ARE IN PLACE TO IDENTIFY THE DEFECT BEFORE THE PRODUCT IS DISTRIBUTED. BASED ON THE PRODUCT INVESTIGATION THERE IS NO EVIDENCE THAT THE FAILURE IS RELATED TO A MANUFACTURING DEFECT. ALL DEVICES PASSED THEIR ASSOCIATED TESTING BEFORE DISTRIBUTION. A FUNDAMENTAL ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. OPPORTUNITIES OF PROCESS ENHANCEMENT WERE IDENTIFIED TO STRENGTHEN THE MANUFACTURING 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE OXIMETRY CENTRAL VENOUS CATHETER, DURING USE. THERE WAS LEAKAGE FROM THE OPTICAL MODULE CONNECTOR OF THE CATHETER. THIS RESULTED IN MEDICATION LOSS OF POTASSIUM. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236649 EDWARDS OXIMETRY CENTRAL VENOUS CATHETER EDWARDS OXIMETRY CENTRAL VENOUS CATHETER DXG EDWARDS LIFESCIENCES X3820SJD 00690103197587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown