BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE, VAMP

    MDR report key: 22391798 · Received July 3, 2025

    Report

    Report Number
    2015691-2025-05409
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    May 27, 2025
    Report Date
    August 14, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    KRA
    UDI-DI
    07460691950085
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. SINCE THE COMPLAINT AFFECTED UNIT WAS NOT RETURNED FOR EVALUATION A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE ASSOCIATED TO MANUFACTURING OR DESIGN COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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

    ADDITIONAL FDA PRODUCT CODE INCLUDES: DXO- TRANSDUCER, PRESSURE, CATHETER TIP. THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. 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 PRESSURE MONITORING SET, THE ARTERIAL LINE WAS SUSPECTED TO HAVE BEEN PULLED BY THE PATIENT. HOWEVER, WHEN APPLYING PRESSURE TO STOP BLEEDING IT WAS NOTED THAT CATHETER WAS STILL IN PLACE IN THE ARTERY, DESPITE A LACK OF SUTURES AND ONLY HELD IN PLACE BY A STANDARD TRANSPARENT DRESSING. PER THE CUSTOMER, IT APPEARED THAT ARTERIAL TUBING SEPARATED FROM LUERLOCK CONNECTION, LEAVING THE CATHETER AND LUERLOCK IN PLACE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794452 TRUWAVE, VAMP CATHETER, CONTINUOUS FLUSH KRA EDWARDS LIFESCIENCES DR PXAVMP3 66118580 07460691950085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown