BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE VAMP PLUS

    MDR report key: 21894142 · Received April 23, 2025

    Report

    Report Number
    2015691-2025-03176
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 23, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXO
    UDI-DI
    07460691950436
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AT THE FACILITY AND IS NOT AVAILABLE TO BE RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD REVIEW IS UNABLE TO BE COMPLETED. AN ENGINEERING EVALUATION HAS BEEN INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. ADDITIONAL PRODUCT CODE, KRA. ADDITIONAL 510K NUMBERS, K181684 AND K896819.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THAT THE ARTERIAL LINE BECAME DETACHED WITH THE PRESSURE MONITORING SET. A FAMILY MEMBER WAS SPLASHED WITH IV SOLUTION, NOT BLOOD. THERE WAS NO HARM OR INJURY TO THE FAMILY MEMBER. THE EDWARDS REPRESENTATIVE PROVIDED ON-SITE EDUCATION. THERE WAS NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272045 TRUWAVE VAMP PLUS PRESSURE MONITORING SET DXO EDWARDS LIFESCIENCES PXVP2284AT3 07460691950436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown