BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROAQT SENSOR

    MDR report key: 22825971 · Received August 18, 2025

    Report

    Report Number
    3003263092-2025-000001
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Report Date
    August 18, 2025
    Manufacturer
    PULSION MEDICAL SYSTEMS SE
    Product Code
    DXG
    UDI-DI
    04250094503338
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION ABOUT THE EVENT HAS BEEN REQUESTED. DEVICE REQUESTED FOR INVESTIGATION. A SUPPLEMENTAL EMDR WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. THIS EVENT OCCURRED ON THE TAIWANESE MARKET ON A DEVICE THAT IS DISTRIBUTED EXCLUSIVELY OUTSIDE OF THE USA. THEREFORE, NO GUDID INFORMATION EXISTS. UDI INFORMATION PROVIDED IN D4 IS FOR THE OUS DEVICE. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO ¿PV8811¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K192169.

    Additional Manufacturer Narrative · 0

    UPON OPENING THE PACKAGE, THE CONNECTION TO THE EXTENSION TUBE WAS NOT PROPERLY TIGHTENED. THE MEDICAL STAFF TIGHTENED IT MANUALLY BEFORE USE BUT IT WAS STILL SLOWLY LEAKING. NO HARM TO THE PATIENT WAS REPORTED. THE RETURNED PRODUCT WAS INVESTIGATED AT MUNUFACTURER SITE, THE CONNECTION WAS LEAK TESTED AND NO LEAKAGE WAS OBSERVED. IT WAS NOT POSSIBLE TO INVESTIGATE THE CONNECTION FURTHER SINCE IT WAS NOT POSSIBLE TO OPEN THE LUER CONNECTORS PROBABLY DUE TO DRIED BLOOD. OUR CONCLUSION IS THAT WE COULD NOT REPRODUCE THE ERROR AND IT IS THEREFORE IMPOSSIBLE TO DEFINE THE ROOT CAUSE. WE CONCLUDE THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS SINCE OUR CUSTOMER REPORTED A MINOR LEAKAGE. THE PROAQT SENSOR PROVIDES THE PULSIOFLEX MONITOR WITH A CONTINUOUS ARTERIAL PRESSURE SIGNAL. A NUMBER OF HEMODYNAMIC PARAMETERS ARE DERIVED FROM THIS SIGNAL. THE MOST IMPORTANT IS THE DETERMINED CARDIA OUTPUT TREND. AN INITIAL CALIBRATION IS NECESSARY FOR CONTINUOUS DETERMINATION OF THE CARDIAC OUTPUT TREND. PATIENT CHARACTERISTICS SUCH AS WEIGHT, HEIGHT, CATEGORY (AGE) AND GENDER ARE USED TO CALCULATE AN INDIVIDUAL CO REFERENCE VALUE WHICH IS USED FOR CALIBRATION. ALTERNATIVELY, CALIBRATION CAN BE PERFORMED BY THE INPUT OF AN EXTERNALLY MEASURED CO VALUE. PRIMARILY, STROKE VOLUME IS DETERMINED FROM THE SYSTOLIC PART OF THE ARTERIAL PRESSURE CURVE AND MULTIPLIED BY THE HEART RATE. THIS RESULTS IN A CONTINUOUS TREND VALUE FOR CARDIAC OUTPUT. FURTHER PARAMETERS DERIVED FROM THIS METHOD INCLUDE E.G. THE SYSTEMIC VASCULAR RESISTANCE (SVR) AND THE STROKE VOLUME VARIATION (SVV).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE CONNECTION TO THE EXTENSION TUBE WAS NOT PROPERLY TIGHTENED. THE LEAKAGE OCCURRED DESPITE THE FACT THAT THE MEDICAL STAFF TIGHTENED IT MANUALLY BEFORE USE. NO HARM OR SERIOUS INJURY WAS REPORTED FOR THIS CASE. MANUFACTURER REFERENCE # (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REF# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044295 PROAQT SENSOR COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG PULSION MEDICAL SYSTEMS SE PV8810 25AA07 04250094503338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown