BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 22870712 · Received August 22, 2025

    Report

    Report Number
    8010762-2025-0000372
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    August 19, 2025
    Report Date
    October 6, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04037691658384
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WILL SUBMITTED WHEN ADDITIONAL INFORMATION BECOME AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE AUSTRALIEN 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.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PRESSURE AUX (PAUX) WAS NOT REGISTERING ANY PRESSURE READING ISSUE. THE FAILURE OCCURRED DURING SERVICE TEST. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE FAILURE WAS REPORTED, WHICH COULD BE A POTENTIAL RISK FOR THE PATIENT, A REPORT IS NEEDED.A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION. THE SENSOR PANEL WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE LOG FILES OF THE REPORTED CARDIOHELP DEVICE WERE REVIEWED AND NO ERROR MESSAGE REGARDING A PRESSURE AUX (PAUX) FAILURE COULD BE CONFIRMED. HOWEVER, THE ERROR MESSAGES "PART SENSOR DISCONNECTED" AND "PINT SENSOR DISCONNECTED" AND "PVEN SENSOR DISCONNECTED" COULD BE CONFIRMED ON THE DATE OF EVENT.THE FST CONFIRMED THAT THERE WERE NO VISIBLE DAMAGES ON THE SENSOR PANEL.A SIMILAR FAILURE WAS INVESTIGATED BY THE GETINGE LIFE-CYCLE-ENGINEERING WITH THE FOLLOWING CONCLUSION: THE FAILURE COULD BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE THAT THE WETTING OF THE SOCKET PLAN FROM THE HLS CONNECTOR AFFECTED THE MEASUREMENT VOLTAGES FOR THE ARTERIAL PRESSURE. THIS LEAD TO THE UNSTABLE VALUE CHANGES OF THE PRESSURE.ACCORDING TO THE INSTRUCTION FOR USE OF THE INVOLVED DISPOSABLES (HLS SET ADVANCED 5.0 / 7.0, HIT SET ADVANCED 5.0 / 7.0, V2.4, CHAPTER "PREPARATION AND INSTALLATION" AND QUADROX-IR SMALL ADULT / ADULT, CHAPTER "PRIMING THE SYSTEM") THE PRESSURE SENSORS HAVE TO BE CALIBRATED AND CHECKED BEFORE PRIMING. FURTHERMORE, THE CARDIOHELP HAS A FLOW/BUBBLE SENSOR AND A VENOUS PROBE TO MEASURE AND CONTROL THE BLOOD FLOW AND PARAMETERS. IF THE MEASURED VALUES ARE ABOVE HIGH LIMIT OR BELOW LOW LIMIT OF THE SET LIMITS THE SYSTEM GENERATES A VISUAL AND ACOUSTICAL ALARM.IN THE INSTRUCTIONS FOR USE (IFU) OF THE CARDIOHELP (CHAPTER "CLEANING AND DISINFECTION") THE CABLES AND THE WHOLE DEVICE SHOULD BE CLEANED AFTER EACH USE TO REMOVE SOILING OR RESIDUAL BLOOD. FURTHERMORE, IN THE IFU CHAPTER "CONNECTING THE SENSORS" IT IS STATED THAT THE SENSORS MUST BE KEPT CLEAN. THE DEVICE WAS MANUFACTURED ON 2018-11-16.THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-09-08 FOR THE PERIOD OF 2018-11-16 TO 225-08-19. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS.BASED ON THE RESULTS THE REPORTED FAILURE "PRESSURE AUX (PAUX) WAS NOT REGISTERING ANY PRESSURE READING ISSUE" COULD BE CONFIRMED.THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT.THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY'S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRESSURE AUX (PAUX) WAS NOT REGISTERING ANY PRESSURE READING ISSUE. THE FAILURE OCCURRED DURING SERVICE TEST. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE FAILURE WAS REPORTED, WHICH COULD BE A POTENTIAL RISK FOR THE PATIENT, A REPORT IS NEEDED. COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727179 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 04037691658384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown