BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 23130632 · Received September 24, 2025

    Report

    Report Number
    8010762-2025-0000416
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 14, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE CHINESE MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO ROTAFLOW CONSOLE WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER: K991864. 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 ROTAFLOW CONSOLE WITH CATALOG NUMBER: 701046405.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE DURING TREATMENT. THE DEVICE WAS IMMEDIATELY RESTARTED AND THE ISSUE WAS RESOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP THEREFORE, A REPORT IS REQUIRED. THE PATIENT DATA WAS NOT SHARED BY CUSTOMER. ACCORDING TO THE SSU (SALES AND SERVICE UNIT) DATED ON 2025-10-13 RESTARTING THE DEVICE SOLVED THE PROBLEM. NO FURTHER ALARM OCCURED. BASED ON THESE INVESTIGATION RESULTS THE REPORTED "HEAD ERROR" COULD BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE "HEAD ERROR" COULD BE DETERMINED AS: 1. THE HEAD ERROR FOLLOWS THE SIG ERROR. WHEN THE ULTRASONIC CREAM IS APPLIED (DUE TO THE SIG ERROR) TO THE FLOW BUBBLE SENSOR AND THE DISPOSABLE IS MOVED CLOSE TO THE ROTA FLOW DRIVE, THE MAGNETS IN THE CENTRIFUGAL PUMP INTERFERE WITH THE SENSORS IN THE ROTA FLOW DRIVE. THIS ERROR CAN BE OVERWRITTEN BY RESTARTING THE ROTA FLOW CONSOLE. 2. IF THE RPM / LPM IS SET TO ZERO AND THE DRIVE AS WELL AS THE INSERTED CENTRIFUGAL PUMP IS SHAKEN THIS CAUSES MAGNETIC UNCOUPLING OF THE CENTRIFUGAL PUMP AND THUS LEADS TO THE HEAD ERROR. THIS ERROR CAN BE OVERWRITTEN BY RESTARTING THE ROTA FLOW CONSOLE. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2025-09-24 AND DURING THE PERIOD OF 2020-02-20 TO 2025-09-22 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 AFFECTED ROTAFLOW DEVICE WAS PRODUCED IN 2020-02-20. 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. FOR THE AFFECTED SERIAL NUMBERS WITHIN THE TIMEFRAME OF THE SEARCH NO ADDITIONAL COMPLAINT WAS FOUND FOR THE SAME ISSUE. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE "HEAD ERROR", THE CUSTOMER WILL BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / 15. CHAPTER 4.1.3: SWITCH OFF THE ROTAFLOW CONSOLE ON/OFF SWITCH BEFORE CONNECTING THE ROTAFLOW DRIVE TO OR DISCONNECTING IT FROM THE ROTAFLOW CONSOLE. OTHERWISE THE ROTAFLOW CONSOLE MAY BE DAMAGED. CHAPTER 2.2.3. TAKE DAMAGED DEVICES OUT OF SERVICE IMMEDIATELY AND HAVE THEM TESTED BY THE AUTHORIZED SERVICE PERSONNEL. THE CUSTOMER WILL ALSO BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE SERVICE MANUAL FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ EN / 03 CHAPTER 1.7 SERVICE-RELATED WORK ON A DEVICE MAY ONLY BE CARRIED OUT BY SERVICE TECHNICIANS WHO HAVE BEEN TRAINED AND INSTRUCTED AND CERTIFIED BY GETINGE. SERVICE-RELATED WORK ON A DEVICE CARRIED OUT BY UNQUALIFIED SERVICE TECHNICIANS MAY LEAD TO INJURY OF THE SERVICE TECHNICIAN, PATIENT OR OTHER PERSONS OR MAY LEAD TO DEVICE DAMAGE. CHAPTER 1.10 A REPAIR IS CARRIED OUT FOR MAINTENANCE AFTER DAMAGE OR MALFUNCTION OF A ROTAFLOW SYSTEM. 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 CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE. NO MORE INFORMATION PROVIDED. MORE INFORMATION REQUESTED BUT STILL PENDING. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP THEREFORE, 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
    579834 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706291#ROTAFLOW CHINESE ZH-PLUG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention