BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 22455358 · Received July 9, 2025

    Report

    Report Number
    8010762-2025-0000291
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 29, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04037691658384
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WILL SUBMITTED WHEN ADDITONAL INFORMATION BECOME AVAILABLE.NOTE: THIS EVENT OCCURRED ON THE CHINESE 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 DRIVE FAN 2 WAS DAMAGED. A FAN ERROR MESSAGE OCCURRED. THE CARDIOHELP WAS REPLACED DURING TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE CARDIOHELP WAS REPLACED DURING TREATMENT, A REPORT IS NEEDED. ACCORDING TO THE GETINGE SERVICE AND SALES UNIT, THE CUSTOMER DECIDED NOT TO REPAIR THE DEVICE, THEREFORE THE EXACT FAILURE REMAINS UNKNOWN. AS NO SERVICE WILL BE PERFORMED BY A GETINGE TECHNICIAN, NO LOG FILES CAN BE ANALYZED. THUS, THE EXACT ROOT CAUSE REMAINS UNKNOWN. HOWEVER, ACCORDING TO THE RISK FILE V24 OF THE CARDIOHELP DEVICE THE FOLLOWING ROOT CAUSES CAN LEAD TO THE REPORTED FAILURE: HIGH SURFACE TEMPERATURE BECAUSE OF E.G.:- DEFECT FANS (FOR COOLING OF PUMP DRIVE, FOR HEAT EXCHANGE, FOR POWER SUPPLY)BLOOD IN DISPOSABLE IS HEATED UP BY THE CARDIOHELP DEVICE E.G. BECAUSE OF:- FAN HEAT EXCHANGE DEFECT- FAN FOR COOLING OF DRIVE DEFECT- LOW HEAT ISOLATION BETWEEN DEVICE AND DISPOSABLE - ROTOR DUE TO CLAMPED TUBE- WRONG CONTROL OF FANS BY SOFTWARE. THE SYSTEM HAS REDUNDANT FANS TO ENSURE A PROPER COOLING EVEN IF ONE FAN MALFUNCTIONS. IN CASE OF A DEFECTIVE FAN A VISUAL AND ACOUSTIC ALARM IS GENERATED. IN ADDITION AN ALARM IS GENERATED IF THE INTERNAL TEMPERATURE IS TOO HIGH. ACCORDING TO THE SERVICE MANUAL (CHAPTER "SERVICE ACTIVITIES") THE FANS HAVE TO BE EXCHANGED EVERY 24 MONTHS DURING THE MAINTENANCE. FURTHERMORE IN THE INSTRUCTION FOR USE (IFU), (CHAPTER "GENERAL RISKS IN THE USE OF HEART-LUNG SUPPORT SYSTEMS") IT IS STATED THAT THE VENTILATION OPENINGS HAVE TO BE CHECKED BEFORE EVERY USE THAT THEY ARE NOT COVERED. A CARDIOHELP WITH A DEFECTIVE FAN SHOULD BE REPLACED AS QUICKLY AS POSSIBLE. THE DEVICE WAS MANUFACTURED ON 2018-07-13. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-07-24 FOR THE PERIOD OF 2018-07-13 TO 2025-06-30. 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 "FAN ERROR MESSAGE" 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 CARDIOHELP WAS EXCHANGED. IT WAS REPORTED THAT THE DRIVE FAN 2 WAS DAMAGED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE CARDIOHELP WAS EXCHANGED, WHICH IS 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
    702534 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 04037691658384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown