BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 23813659 · Received December 16, 2025

    Report

    Report Number
    8010762-2025-0000550
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 28, 2025
    Report Date
    December 30, 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 BATTERY LIFE IS SHORT DURING AN INTRA-HOSPITAL PATIENT TRANSPORT. THE BATTERY DRAINS QUICKLY (ESTIMATED LIFESPAN OF 30 MINUTES), AND THE CUSTOMER HAD TO USE THE EMERGENCY DRIVE DURING THE TRANSPORT UNTIL THE DEVICE WAS PLUGGED TO AC POWER AGAIN. THE BATTERY IS OVERDUE FOR REPLACEMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. SINCE THE EMERGENCY DRIVE HAD TO BE USED, THE EVENT CAN RESULT IN A RISK FOR HARM OF ANY PERSON. THEREFORE, A REPORT IS REQUIRED. THE PATIENT DATA WAS NOT SHARED BY CUSTOMER DUE TO PATIENT PRIVACY. THE AFFECTED ROTAFLOW CONSOLE WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND THE TECHNICIAN WAS ABLE TO REPRODUCE THE REPORTED FAILURE. THE BATTERY PACK FOR RFC (ARTICLE NUMBER 701017188) HAS BEEN REPLACED. AFTER REPLACEMENT THE DEVICE PASSED ALL FACTORY-SPECIFIED PERFORMANCE AND SAFETY TESTS AND IS CLEARED FOR CLINICAL USE. THE ROOT CAUSE FOR THE BATTERY FAILURE COULD BE DETERMINED AS THE LIFETIME OF THE BATTERY WAS PASSED AND REPLACEMENT OVERDUE. THE AFFECTED BATTERY WAS IN USE FOR MORE THAN TWO YEARS. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED. IN ORDER TO INVESTIGATE FURTHER THE COMPLAINT INFORMATION WAS TRANSFERRED INTO A NON-CONFORMANCE, THUS THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2025-12-30 AND DURING THE PERIOD OF 2020-03-03 TO 2025-12-01 IT SHOWS TWO NON-CONFORMITIES IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THE AFFECTED ROTAFLOW CONSOLE WAS PRODUCED IN 2020-03-03. 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 BATTERY LIFE IS SHORT DURING AN INTRA-HOSPITAL PATIENT TRANSPORT. THE BATTERY DRAINS QUICKLY (ESTIMATED LIFESPAN OF 30 MINUTES), AND THE CUSTOMER HAD TO USE THE EMERGENCY DRIVE DURING THE TRANSPORT UNTIL THE DEVICE WAS PLUGGED TO AC POWER AGAIN. THE BATTERY IS OVERDUE FOR REPLACEMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. SINCE THE EMERGENCY DRIVE HAD TO BE USED, 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: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278141 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