BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 23062522 · Received September 16, 2025

    Report

    Report Number
    8010762-2025-0000408
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    September 1, 2025
    Report Date
    September 16, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    4058863074863
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INITIALLY REPORTED THAT THE CARDIOHELP WAS READING ERRATIC READINGS. INFORMATION RECEIVED ON (B)(6) 2025 THAT DURING TREATMENT, THE ARTERIAL BUBBLE DETECTION COULD NOT BE CANCELLED OR BE RESET. THE CARDIOHELP WAS EXCHANGED. THE HLS SET WILL BE FURTHER INVESTIGATED IN COMPLAINT # (B)(4), MFG REPORT NUMBER # 8010762-2025-0000404. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THERE WAS A PUMP STOP DURING TREATMENT AND THE CARDIOHELP WAS EXCHANGED, THEREFORE A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION ON 2025-09-05. THE FAILURE COULD NOT BE REPLICATED. NO PARTS WERE 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 ¿ARTERIAL BUBBLE DETECTED¿ COULD BE CONFIRMED. AS THE FAILURE COULD NOT BE REPLICATED, NO EXACT ROOT CAUSE COULD BE DETERMINED. HOWEVER, ACCORDING TO THE RISK FILE V24 OF THE CARDIOHELP DEVICE THE FOLLOWING ROOT CAUSES CAN LEAD TO THE REPORTED FAILURE: BUBBLE INTERVENTION NOT WORKING WRONG INFORMATION - INFLUENCE DUE TO OTHER ULTRASONIC DEVICES (E.G. FLOW SENSOR). - ENVIRONMENTAL INFLUENCES (ATMOSPHERIC PRESSURE, TEMPERATURE, HUMIDITY, EMI, OVERVOLTAGE). ACCORDING TO THE INSTRUCTION FOR USE (IFU) CHAPTER "CONNECTING THE COMBINED FLOW/BUBBLE SENSOR" THE BUBBLE MONITORING FUNCTION TEST AND FLOW OFF-SET CALIBRATION HAS TO BE PERFORMED BEFORE EVERY USE. THUS A DEFECTIVE FLOW/BUBBLE SENSOR SHOULD BE DETECTED PRIOR TO USE, DURING PRIMING. IN ADDITION AS THE CARDIOHELP INCLUDES PRESSURE SENSORS AND A VENOUS PROBE IT IS ABLE 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 IFU CHAPTER "USING THE EMERGENCY DRIVE WITH THE DISPOSABLE HLS RETAINER" IS STATED THAT THE EMERGENCY DRIVE CAN BE USED TO MANUALLY CONTROL THE BLOOD FLOW IN CASE OF A FAILED CARDIOHELP. ACCORDING TO THE 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 CHAPTER "CONNECTING THE SENSORS" IT IS STATED THAT THE SENSORS MUST BE KEPT CLEAN. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-09-04 FOR THE PERIOD OF 2022-01-10 TO 2025-09-02. 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. THE DEVICE WAS MANUFACTURED ON 2022-01-10. 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 "ARTERIAL BUBBLE SENSOR " COULD BE CONFIRMED WITHIN THE LOGFILES, BUT COULD NOT BE REPLICATED. 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 INITIALLY REPORTED THAT THE CARDIOHELP WAS READING ERRATIC READINGS. INFORMATION RECEIVED ON (B)(6) 2025 THAT DURING TREATMENT, THE ARTERIAL BUBBLE DETECTION COULD NOT BE CANCELLED OR BE RESET. THE CARDIOHELP WAS EXCHANGED. THE HLS SET WILL BE FURTHER INVESTIGATED IN COMPLAINT # (B)(4). NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THERE WAS A PUMP STOP DURING TREATMENT AND THE CARDIOHELP WAS EXCHANGED, THEREFORE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2680504 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 4058863074863

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male