BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE

    MDR report key: 19945698 · Received August 8, 2024

    Report

    Report Number
    2015691-2024-06008
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 24, 2024
    Report Date
    March 13, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXO
    UDI-DI
    00690103148190
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED AT THE FACILITY. THE DEVICE HISTORY RECORD REVIEW IS PENDING. ONCE IT HAS BEEN COMPLETED THE RESULTS WILL BE SENT IN A SUPPLEMENTAL SUBMISSION. ADDITIONAL PRODUCT CODE, KRA, CATHETER, CONTINUOUS FLUSH. ADDITIONAL 510K K896819.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AT THE FACILITY AND CANNOT BE RETURNED FOR PRODUCT EVALUATION. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON CONFORMANCES. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE ISSUE. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED WITH A MANUFACTURING OR DESIGN DEFECT. IT IS NOT KNOWN IF PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. 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 THE MONTHLY REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS CONTAMINATION FOUND IN THE THREE WAY STOPCOCK OF A PRESSURE MONITORING ACCESSORY. THE APPEARANCE WAS FOREIGN MATERIAL. THE CONTAMINATION WAS FOUND DURING PATIENT USE. THE USER MADE THE DECISION TO COMPLETE THE PROCEDURE USING THE DEVICE. THE DEVICE WAS DISCARDED AFTER THE PROCEDURE WAS COMPLETED. PATIENT DEMOGRAPHICS ARE UNAVAILABLE. THERE IS NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635163 TRUWAVE TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES MKP01464 ZC1322MT 00690103148190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown