BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE, VAMP PLUS

    MDR report key: 25123479 · Received May 8, 2026

    Report

    Report Number
    2015691-2026-15006
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    December 30, 2025
    Report Date
    May 8, 2026
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    KRA
    UDI-DI
    07460691949911
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: DXO- TRANSDUCER, PRESSURE, CATHETER TIP. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE TRUWAVE, THE NURSE NOTICED THAT THE PRESSURE BAG FOR THE 3-WAY PRESSURE INFUSING TUBING HAD BEEN CHANGED TWO TIMES SINCE PATIENT HAD GOTTEN BACK FROM HEART SURGERY AT 13: 00. AFTER INVESTIGATING, THE NURSE FOUND THAT CVP HAD A SLOW LEAK AND PATIENT HAD BEEN RECEIVING THE FLUIDS OVER THE COURSE OF ONE AND A HALF SHIFTS. CHANGED TUBING AND THE ISSUE RESOLVED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416460 TRUWAVE, VAMP PLUS CATHETER, CONTINUOUS FLUSH KRA EDWARDS LIFESCIENCES DR PXVP0550 66488542 07460691949911

    Patients

    Seq Age Sex Outcome Treatment
    1