BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 22975237 · Received September 5, 2025

    Report

    Report Number
    8010762-2025-0000388
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Report Date
    December 24, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    UDI-DI
    04037691718910
    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 "BASE UNIT, 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 ROTAFLOW DRIVE (RFD) MAKES AN ABNORMAL NOISE DURING USE. THE DEVICE HAS BEEN REPLACED FOR TREATMENT. IN ADDITION, A BATTERY ERROR HAS OCCURRED. THE BATTERY NEEDS TO BE REPLACED ACCORDING TO THE SERVICE INTERVAL. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE PATIENT DATA WAS NOT SHARED BY CUSTOMER. SINCE THE DEVICE WAS EXCHANGED DURING PATIENT TREATMENT, WHICH STOPS TREATMENT FOR A MOMENT, THE EVENT CAN RESULT IN A RISK FOR HARM OF ANY PERSON. THEREFORE, A REPORT IS REQUIRED. THE AFFECTED ROTAFLOW CONSOLE WITH SN (B)(6) AND THE AFFECTED ROTAFLOW DRIVE (RFD) WITH S/N (B)(6) WERE INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND THE REPORTED FAILURES COULD BE CONFIRMED. ACCORDING TO THE SALES AND SERVICE UNIT (SSU) DATED ON 2025-09-08 THE BATTERY FOR THE ROTAFLOW CONSOLE WILL BE REPLACED AS SOON AS THE SPARE BATTERY ARRIVES. THE AFFECTED ROTAFLOW DRIVE WAS SENT TO GETINGE SERVICE DEPARTMENT IN GERMANY VIA RMA0002735. ON 2025-11-24 THE FAILURE "ABNORMAL NOISE" COULD BE CONFIRMED BY THE SERVICE DEPARTMENT AND IN ADDITION IT WAS FOUND THAT THE CLOSING ASSY IS DAMAGED. THEREFORE THE DRIVE HAS BEEN SENT TO THE SUPPLIER EMTEC FOR REPAIR ON 2025-12-04. IF THE DEVICE HAS BEEN REPAIRED AND FURTHER SIGNIFICANT INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE REOPENED AND NECESSARY STEPS WILL BE INITIATED. NO EXACT ROOT CAUSE FOR THE REPORTED NOISE ON THE ROTAFLOW DRIVE (RFD) COULD BE DETERMINED AT THIS TIME, SINCE THE RFD NEEDS TO BE REPAIRED BY THE SUPPLIER EMTEC. HOWEVER, THE FAILURE MODE "RFD LOUD NOISE" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO THE ROTAFLOW RISK MANAGEMENT FILE: - FALLING OF ROTAFLOW SYSTEM (BROKEN HOLDER, USER ROUTINE VIOLENCE) - COLLISION WITH ENVIRONMENT DURING PATIENT TRANSPORT - USER TRIPS OVER CABLES OR TUBES - LOOSENING OF FASTENING (WRONG INSTALLATION, AGING) - SYSTEM FALLS TO GROUND (TRANSPORT IN NON-FIXED MANNER, USER ROUTINE VIOLATION) - GENERAL MECHANIC DISTURBANCES, NOISE. IN ADDITION THE REPORTED FAILURE "NOISE ON ROTAFLOW DRIVE" WAS INVESTIGATED IN SIMILAR COMPLAINTS BY THE SUPPLIER EMTEC, WITH THE ROOT CAUSE OF WORN BEARINGS AND CORROSION INSIDE THE RFD WHICH LED TO THE REPORTED FAILURE. THE REPORTED FAILURE "CLOSING ASSY BROKEN" WAS ALREADY INVESTIGATED BY GETINGE LIFECYCLE ENGINEERING (LCE). MOST PROBABLE ROOT CAUSES COULD BE DETERMINED: - TOO EXCESSIVE FORCE - WEAKENING DUE TO MANUFACTURING ERRORS (AIR INCLUSIONS) - WEAKENING DUE TO AGING. UV LIGHT (SUN) OR CONTACT WITH CHEMICALS. THE ROOT CAUSE FOR THE ADDITIONAL REPORTED BATTERY FAILURE COULD BE DETERMINED AS THE LIFETIME OF THE BATTERY WAS PASSED AND REPLACEMENT OVERDUE, SINCE THE BATTERY REACHED ITS USEFUL LIFETIME. THE BATTERY HAS BEEN USED FOR MORE THAN TWO YEARS. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURES COULD BE CONFIRMED. ROTAFLOW CONSOLE: THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2025-12-24 AND DURING THE PERIOD OF 2023-05-10 TO 2025-09-01 IT SHOWS A NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE "BATTERY LIFE TIME OVERDUE". THE AFFECTED ROTAFLOW CONSOLE WITH S/N (B)(6) WAS PRODUCED IN 2023-05-10. 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. ROTAFLOW DRIVE: THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-12-24 FOR THE PERIOD OF 2023-05-10 TO 2025-09-01. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURES (NOISY RFD AND CLOSING ASSY DAMAGED). THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE ROTAFLOW DRIVE WITH S/N (B)(6) WAS PRODUCED IN 2023-05-10. 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. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE, IT IS NECESSARY TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / 15. CHAPTER 3.3.4: CHECK BATTERY CAPACITY EVERY 6 MONTHS, AT THE LATEST. THE BATTERY MUST BE REPLACED BY THE AUTHORIZED TECHNICAL SERVICE EVERY 2 YEARS, AT THE LATEST. THE BATTERY MUST BE REPLACED SOONER IF IT CANNOT BE FULLY CHARGED WITHIN 8.5 HOURS OR IF THE SYSTEM CANNOT BE OPERATED WITH THE FULLY CHARGED BATTERY. THE ACTUAL RUN TIME DURING BATTERY OPERATION DEPENDS ON THE AGE AND CONDITION OF THE BATTERIES, CURRENT CONSUMPTION OF THE ROTAFLOW CONSOLE AND OTHER FACTORS. THE RUN TIME SHOWN IS ONLY A REFERENCE VALUE. THE ACTUAL RUN TIME CAN BE SHORTER OR LONGER. CHAPTER 5.6.1: BEFORE STARTING THE APPLICATION, CHECK THE POINTS LISTED IN "CHECK BEFORE EVERY USE". BEFORE EACH USE, ENSURE THAT THE BATTERIES ARE FULLY CHARGED. IF THE BATTERY CAPACITY IS LOW AN ACOUSTIC SIGNAL SOUNDS ON THE DEVICE. 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 ROTAFLOW DRIVE (RFD) MAKES AN ABNORMAL NOISE DURING USE. THE DEVICE HAS BEEN REPLACED FOR TREATMENT. IN ADDITION, A BATTERY ERROR HAS OCCURRED. THE BATTERY NEEDS TO BE REPLACED, SINCE THE BATTERY LIFETIME IS EXPIRED, AND REPLACEMENT IS OVERDUE ACCORDING TO THE SERVICE INTERVAL. NO HARM TO ANY PERSON HAS BEEN REPORTED. SINCE THE DEVICE WAS EXCHANGED DURING PATIENT TREATMENT, WHICH STOPS TREATMENT FOR A MOMENT, THE EVENT CAN RESULT IN A RISK FOR HARM OF ANY PERSON. THEREFORE, A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID: 1359716

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225629 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706291#ROTAFLOW PUMP MODULE 04037691718910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown