BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 23388518 · Received October 27, 2025

    Report

    Report Number
    8010762-2025-0000476
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Report Date
    January 14, 2026
    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 ERROR MESSAGE ¿REFERENC ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE AFTER TURNING ON THE DEVICE. THE DEVICE WAS NOT USED ON A PATIENT. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED ¿REFERENC ERROR¿ COULD LEAD TO A PUMP STOP DURING USE THEREFORE A REPORT IS REQUIRED. AS STATED BY THE GETINGE SSU (SALES AND SERVICE UNIT) DATED ON 2026-01-12 THE CUSTOMER DID NOT ORDERED ANY REPAIR/SERVICE OF THE DEVICE BY GETINGE. NO PARTS HAS BEEN REPLACED. THE DEVICE IS OUT OF USE. HOWEVER, SIMILAR COMPLAINT WAS INVESTIGATED FOR THE REPORTED FAILURE "REFERENC ERROR" IN THE GETINGE LIFE-CYCLE-ENGINEERING (LCE) AND WAS CAUSED MOST PROBABLY BY A DEFECT CAPACITOR C44 ON THE FLOW MEASURE BOARD, WHICH LED TO A REDUCED RESISTANCE IN THE +12V SUPPLY VOLTAGE. THIS TRIGGERED THE FUSE F2 ON THE POWER SUPPLY BOARD. THE CONTROL SYSTEM THEREFORE RELEASED THE ERROR MESSAGES "ERROR REFERENC" AND STOPPED THE ROTAFLOW DRIVE. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2025-10-01 AND DURING THE PERIOD OF 2020-12-08 TO 2025-10-24 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 ROTAFLOW CONSOLE IN QUESTION WAS PRODUCED IN 2020-12-08. 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. IT IS NECESSARY TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM AND THE SERVICE MANUAL HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM CHAPTER 2.2.3. TAKE DAMAGED DEVICES OUT OF SERVICE IMMEDIATELY AND HAVE THEM TESTED BY THE AUTHORIZED SERVICE PERSONNEL. 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 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 ¿REFERENCE ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE AFTER TURNING ON THE DEVICE. THE DEVICE WAS NOT USED ON A PATIENT. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED ¿REFERENCE ERROR¿ COULD LEAD TO A PUMP STOP DURING USE 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
    2733846 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706291#ROTAFLOW CHINESE ZH-PLUG 04037691718910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown