BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 23153512 · Received September 26, 2025

    Report

    Report Number
    8010762-2025-0000423
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 16, 2025
    Report Date
    December 2, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    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 GETINGE SERVICE TECHNICIAN WILL INVESTIGATE THE AFFECTED CARDIOHELP. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE AUSTRALIAN 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 CUSTOMER WAS UNABLE TO GET ANY FLOW DURING TREATMENT. THE EMERGENCY DRIVE WAS USED. THE CARDIOHELP DEVICE WAS REPLACED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE FLOW STOPPED, THE EMERGENCY DRIVE WAS USED AND THE CARDIOHELP DEVICE WAS REPLACED, A REPORT IS REQUIRED. NEW INFORMATION RECEIVED ON 2025-10-06 THAT IT IS NOT POSSIBLE TO GET THE REQUESTED PATIENT INFORMATION FROM THE CUSTOMER. FURTHER IT WAS CONFIRMED THAT AFTER REPLACING THE CARDIOHELP DEVICE, THERE WAS NO FLOW ISSUE. THEREFORE THE HLS SET CAN BE EXCLUDED AS A POSSIBLE CAUSE. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION ON 2025-10-15. THE FST PERFORMED FLOW TESTS FOR SEVERAL HOURS AND WAS UNABLE TO REPLICATE THE REPORTED FAILURE. NO PART WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE FAILURE COULD NOT BE REPRODUCED BY THE GETINGE SERVICE AND SALES UNIT, THEREFORE NO EXACT ROOT CAUSE COULD BE DETERMINED FOR THE REPORTED FAILURE. ACCORDING TO THE RISK FILE OF THE CARDIOHELP DEVICE THE FOLLOWING ROOT CAUSES CAN LEAD TO THE REPORTED FAILURE: WRONG FLOW/ NO FLOW INFORMATION DUE TO:- CONNECTION OF NON-COMPATIBLE SENSORS- IMPAIRED CALIBRATION, INITIALIZATION OF THE FLOW SENSOR- INSUFFICIENT FIXATION OF FLOW CLAMP (FLOW CLAMP NOT CLOSED)- RESPONSE TIME IS TOO LONG. 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. REFERRING 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 2025-12-02 FOR THE PERIOD OF 2016-07-21 TO 2025-09-16. 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 2016-07-21. 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 "ISSUES GETTING FLOW" COULD NOT 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

    THE EVENT OCCURRED IN AUSTRALIA, DURING TREATMENT. IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO GET ANY FLOW. THE EMERGENCY DRIVE WAS USED. THE CARDIOHELP DEVICE WAS REPLACED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE FLOW STOPPED, THE EMERGENCY DRIVE WAS USED AND THE CARDIOHELP DEVICE WAS REPLACED, A REPORT IS REQUIRED. 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
    2124510 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown