BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE, VAMP PLUS

    MDR report key: 22580981 · Received July 23, 2025

    Report

    Report Number
    2015691-2025-06001
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 8, 2025
    Report Date
    September 9, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    UDI-DI
    07460691950177
    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

    PER ADDITIONAL INFORMATION FROM INITIAL REPORTER, THERE WERE NO ERROR MESSAGES DURING THE EVENT. THE TRANSDUCER WAS ATTACHED TO A PHILLIPS MONITOR WITH X2 EXTENSION. STAFF TRIED MULTIPLE EXTREMITIES, BOTH RIGHT AND LEFT SIDES, MANUAL AND AUTOMATIC CUFFS. THE MANUAL AND AUTOMATIC CUFFS ALWAYS CORRELATED, BUT THE ARTERIAL LINE SYSTOLIC BLOOD PRESSURE WAS CONSISTENTLY HIGHER. THIS DEVICE WAS PREVIOUSLY REPORTED AS AVAILABLE FOR RETURN; HOWEVER, THE REPORTER CONFIRMED THAT THE DEVICE WAS NO LONGER AVAILABLE. 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. THE INSTRUCTIONS FOR USE (IFU) STATES "PRESSURE READINGS CAN CHANGE QUICKLY AND DRAMATICALLY BECAUSE OF LOSS OF PROPER CALIBRATION, LOOSE CONNECTION, OR AIR IN THE SYSTEM. AND "ABNORMAL PRESSURE READINGS SHOULD CORRELATE WITH THE PATIENT'S CLINICAL MANIFESTATIONS." INSTRUCTIONS INCLUDE TESTING DYNAMIC RESPONSE AND NOTES THAT POOR DYNAMIC RESPONSE CAN BE CAUSED BY AIR BUBBLES, CLOTTING, EXCESSIVE LENGTHS OF TUBING, EXCESSIVELY COMPLIANT PRESSURE TUBING, SMALL BORE TUBING, LOOSE CONNECTIONS, OR LEAKS. WARNING: MOISTURE WITHIN THE CONNECTOR MAY RESULT IN THE DEVICE MALFUNCTIONING OR IN INACCURATE PRESSURE READINGS. IF THIS OCCURS, REPLACE WET PART OR PARTS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA CODES: KRA. ADDITIONAL PREMARKET SUBMISSION: K181684, K896819. 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 IN THE INTENSIVE CARE UNIT, THE SYSTOLIC BLOOD PRESSURE READING OF A PRESSURE MONITORING KIT WAS 40 TO 100 POINTS HIGHER THAN BOTH THE MANUAL AND AUTOMATIC CUFF PRESSURES. THOUGH THE MEAN ARTERIAL PRESSURE READINGS DID NOT CORRELATE, THE DIASTOLIC BLOOD PRESSURES WERE SIMILAR. ISSUE WAS RESOLVED BY REVIEWING THE CASE WITH A DOCTOR. NO ALLEGATIONS OF PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000992 TRUWAVE, VAMP PLUS TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR PXVP2284 66200794 07460691950177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown