BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 25240924 · Received May 21, 2026

    Report

    Report Number
    8010762-2026-0000242
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 20, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04037691658384
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE TECHNICIAN WAS SENT FOR INVESTIGATION ON 2026-05-05. THE TECHNICIAN NOTICED A VERY HIGH OFFSET. THE FLOW MEASUREMENT SHOWED APPROXIMATELY 5 L/MIN AT STARTUP AT 0 RPM, BUT AFTER ZEROING THE PRESSURE, THE MEASUREMENT WORKED PERFECTLY. OPENED AND CLEANED THE CONNECTOR ON THE SENSOR; CLEANED THE CONNECTOR BETWEEN THE SENSOR AND THE CARDIOHELP USING CONTACT SPRAY AND WAS THUS ABLE TO ELIMINATE THE OFFSET. THE TECHNICIAN PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE INVESTIGATION IS ONGOING. A FOLLOW UP WILL SUBMITTED WHEN ADDTIONAL INFORMATION BECOME AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE GERMAN MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, CARDIOHELP¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K133598. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR CARDIOHELP WITH CATALOG NUMBER 701048012.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN GERMANY DURING TREATMENT. IT WAS REPORTED THAT THE FLOW BUBBLE SENSOR STARTED SHOWING FLUCTUATING READINGS. NO CORROSION WAS VISIBLE ON EITHER THE PANEL OR THE FLOW BUBBLE SENSOR CONNECTOR. THE CARDIOHELP WAS REPLACED WITH ANOTHER ONE AND THE TREATMENT CONTINUED. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432095 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 04037691658384

    Patients

    Seq Age Sex Outcome Treatment
    1