BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE, VAMP PLUS

    MDR report key: 23525843 · Received November 11, 2025

    Report

    Report Number
    2015691-2025-09197
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 16, 2025
    Report Date
    December 16, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    KRA
    UDI-DI
    07460691950177
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PRODUCT EVALUATION AS THE DEVICE WAS NOT RETURNED. WITHOUT ITS RETURN, IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS DAMAGE OR A DEFECT THAT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS THE COMPLAINT COULD NOT BE CONFIRMED, THERE IS NOT SUFFICIENT EVIDENCE TO DETERMINE A ROOT CAUSE. AS PART OF THE MANUFACTURING PROCESS 100 PERCENT OF THE UNITS GO THROUGH A BALLOON INSPECTION PROCESS. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON CONFORMANCES.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE IS STILL IN USE. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. D2B: ADDITIONAL COMMON DEVICE NAMES: DXO- TRANSDUCER, PRESSURE, CATHETER TIP G4: ADDITIONAL PMA/510K NUMBERS: K181684, K896819 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 DURING USE WITH THE PRESSURE MONITORING SET THAT THE ARTERIAL PRESSURE (SYSTOLIC, DIASTOLIC, AND MEAN) DID NOT CORRELATE WITH NIBP AND MANUAL PRESSURE. ADDITIONAL INFORMATION PROVIDED: NO ERROR MESSAGE OR ABNORMAL WAVEFORM WAS REPORTED. PATIENT OUTCOME IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122739 TRUWAVE, VAMP PLUS CATHETER, CONTINUOUS FLUSH KRA EDWARDS LIFESCIENCES DR PXVP2284 66521704 07460691950177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown