BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE

    MDR report key: 22986106 · Received September 5, 2025

    Report

    Report Number
    2015691-2025-07325
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    July 6, 2025
    Report Date
    October 21, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K142749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PREMARKET SUBMISSION: K171996, K183413. IT IS NOT KNOWN IF THE DEVICE WILL BE RETURNED. 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. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED. 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. 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 PART OF THE MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    IT WAS PREVIOUSLY REPORTED THAT THE DEVICE WOULD NOT BE RETURNED. DEVICE WAS EVENTUALLY RETURNED AFTER MULTIPLE ATTEMPTS WERE MADE. A PRODUCT EVALUATION WAS COMPLETED WITH THE RETURNED PRESSURE MONITORING DEVICE. THE REPORTED EVENT OF PIGTAIL BROKE WAS CONFIRMED. AS RECEIVED, THE SNAP-TAB OF DPT FLUSH DEVICE HAD BEEN COMPLETELY BROKEN AT THE BOTTOM OF THE POPPET. CROSS SURFACES AT THE SITE OF DAMAGE APPEARED ROUGH AND UNEVEN. NO VISIBLE DEFECT WAS OBSERVED FROM POPPET CAP OR RETURNED UNIT. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION AND EVALUATION, A STRESS PROBLEM WAS IDENTIFIED AND CAUSE IS TRACED TO MANUFACTURING. A PRODUCT RISK ASSESSMENT WAS INITIATED AND A CORRECTIVE AND PREVENTATIVE ACTION PLAN WAS OPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, WHILE FLUSHING WASTE BLOOD BACK INTO THE PATIENT, THE PIGTAIL OF A PRESSURE MONITOR KIT VAMP BROKE. THE BREAKAGE RESULTED IN BLOOD OCCLUDING THE ART LINE TUBING. ONLY THE TRANSDUCER WAS REPLACED. BLOOD SAT IN THE TUBING FOR ABOUT 10 MINUTES. THE TEAM THEN EXPERIENCED INACCURATE VALUES. IT WAS NOTED THAT THE PATIENT WAS ON TWO VASOPRESSORS. ISSUE OCCURRED IN THE PEDIATRIC INTENSIVE CARE UNIT. NO ALLEGATIONS OF PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236607 TRUWAVE TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR PX260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown