BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE

    MDR report key: 21821331 · Received April 10, 2025

    Report

    Report Number
    2015691-2025-02814
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Report Date
    April 10, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K142749
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO PRODUCT EVALUATION RESULTS AS THE DEVICE WAS DISCARDED AND 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. 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. 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 THIS MONTHLY REVIEW. ADDITIONAL FDA PREMARKET SUBMISSION: K171996 AND K183413.

    Description of Event or Problem · 0

    EDWARDS LIFESCIENCES WAS NOTIFIED VIA A DIRECT VOLUNTARY INCIDENT REPORT SUBMISSION TO THE FDA THAT, DURING USE, A TRUWAVE TRANSDUCER HAD NEGATIVE ICP (INTRACRANIAL PRESSURE) READINGS. INITIAL ICP READINGS WERE APPROPRIATE, BUT WHILE EVD (EXTERNAL VENTRICULAR DRAIN) WAS CLAMPED, ICP PRESSURE READING TRENDED NEGATIVE UNTIL VALUES WERE NO LONGER WITHIN RANGE. TRANSDUCER WAS RELEVELED BUT ISSUE CONTINUED. STAFF THEN TRIED TO RE-ZERO THE DEVICE BUT MONITOR WAS UNABLE TO DUE TO "EXCESS OFFSET". PRESSURE CABLE WAS REPLACED TO RE-ZERO, BUT DEVICE WAS UNABLE TO BE ZEROED APPROPRIATELY. OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS OCCURRED, BUT DETAILS WERE NOT PROVIDED IN REPORT. THERE IS NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2269404 TRUWAVE TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR PX284

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other