BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE

    MDR report key: 24949062 · Received April 22, 2026

    Report

    Report Number
    2015691-2026-14581
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 31, 2026
    Report Date
    May 30, 2026
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    UDI-DI
    07460691950214
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS 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. G4. ADDITIONAL PMA/510K: K171996, K183413.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE TRUWAVE PRESSURE MONITORING SET HAD BLOOD/SALINE FREE FLOWING THROUGH TRANSDUCER. THE PATIENT RECEIVED NS BOLUS VIA ARTERIAL LINE. IT IS UNKNOWN IF PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141329 TRUWAVE TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR PX284 67122581 07460691950214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown