BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE, VAMP

    MDR report key: 24334256 · Received February 13, 2026

    Report

    Report Number
    2015691-2026-11089
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    December 24, 2025
    Report Date
    February 24, 2026
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    KRA
    UDI-DI
    07460691955097
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES INCLUDE. DXO TRANSDUCER, PRESSURE, CATHETER TIP. 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 A LOT NUMBER WAS NOT 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

    A CORRECTION IS BEING SUBMITTED DUE TO PRODUCT EVALUATION FINDINGS. ONE PRESSURE MONITORING SET WAS RETURNED FOR EVALUATION. REPORT OF TUBING TO THE VAMP DISCONNECTED WAS CONFIRMED. AS RECEIVED PRESSURE TUBING WAS FOUND COMPLETELY BROKEN FROM THE BOND JOINT VAMP ADULT RESERVOIR. CROSS SURFACES OF BROKEN TUBING APPEARED ROUGH AND UNEVEN. THEREFORE, THIS IS NO LONGER CONSIDERED TO BE A REPORTABLE EVENT. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM RETURNED KIT. THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED DURING USE THE PRESSURE MONITORING SET HAD BLOOD THAT BACKED UP INTO THE VAMP AND THE RN ATTEMPTED TO APPLY PRESSURE TO THE VAMP PLUNGER TO RETURN THE BLOOD. UPON DOING SO, THE TUBING PROXIMAL TO THE VAMP ON THE PATIENTS SIDE DISCONNECTED AT THE CONNECTION POINT. NO AIR WAS INTRODUCED AND THERE WAS MINIMAL BLOOD LOSS AS THE NURSE WAS PRESENT AT THE TIME OF DISCONNECTION. THE VAMP TUBING WAS CHANGED IMMEDIATELY. THERE WAS NO PATIENT INJURY. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394865 TRUWAVE, VAMP CATHETER, CONTINUOUS FLUSH KRA EDWARDS LIFESCIENCES DR PXVMP172 07460691955097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown