BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 25274485 · Received May 26, 2026

    Report

    Report Number
    8010762-2026-0000255
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    May 3, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    UDI-DI
    04037691525532
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN SOUTH KOREA. IT WAS REPORTED THAT ON (B)(6) 2026 THE ROTAFLOW CONSOLE IN THE CCU (CORONARY CARE UNIT) WAS SHUTTING OFF DURING PATIENT TREATMENT. ON 2026-05-04 THE GETINGE FIELD SERVICE TECHNICIAN INVESTIGATED THE DEVICE, AND THE ON/OFF SWITCH WAS IDENTIFIED AS FAULTY. NO HARM TO ANY PERSON HAS BEEN REPORTED. ON 2026-05-11 THE SSU (SALES AND SERVICE UNIT) PROVIDED NEW INFORMATION AS FOLLOWS: WHEN THE EVENT OCCURRED, THE DEFECTIVE DEVICE WAS REPLACED WITH ANOTHER UNIT. THE DEVICE SHUT DOWN WITHOUT ANY MESSAGE DUE TO THE DEFECTIVE ON/OFF SWITCH. SINCE THE ENGINEER IDENTIFIED THAT THE ON/OFF SWITCH COULD NOT REMAIN FIXED IN THE ON POSITION, IT APPEARS THAT THE SWITCH MOVED TO THE OFF POSITION WHEN THE SHUTDOWN OCCURRED. THE PATIENT DATA WAS NOT SHARED BY CUSTOMER. DUE TO THE REPORTED SHUTDOWN DURING PATIENT USE A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN INVESTIGATED THE AFFECTED ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6) AND COULD CONFIRMED THE REPORTED FAILURE. THE ON/OFF SWITCH WITH CABLING WAS DETECTED AS DEFECTIVE. THE SWITCH COULDN'T BE LOCKED IN THE "ON" POSITION. THE ON/OFF SWITCH WITH CABLING (ARTICLE NUMBER 701050674) HAS BEEN REPLACED. AFTER THE REPLACEMENT THE DEVICE WAS WORKING AS INTENDED AND IS BACK IN USE. A ON/OFF SWITCH (ARTICLE NUMBER 701050674) WAS ALREADY INVESTIGATED BY THE GETINGE LIFE-CYCLE-ENGINEERING (LCE) IN A PREVIOUS COMPLAINT AND THE MOST PROBABLE ROOT CAUSE COULD BE DETERMINED AS WEAR AND TEAR OF THE ON/OFF SWITCH BY THE MANUFACTURER. THE LOCKING MECHANISM, WAS WORN OUT WHICH LEAD TO THE REPORTED FAILURE. THE AFFECTED ROTAFLOW CONSOLE WAS PRODUCED IN 2016. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2026-05-08 AND DURING THE PERIOD OF 2016-03-243 TO 2026-05-07 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 CONSOLE WAS PRODUCED IN 2016-03-24. 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. THE FOLLOWING IFU SECTION SHOULD BE FOLLOWED IN CASE OF A "PUMP STOP" HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / 15. CHAPTER 2.2.4 GENERAL PRECAUTIONARY MEASURES DURING USE IF THE PUMP STOPS DURING AN APPLICATION, THE BLOOD FLOW WILL BE INTERRUPTED AND SUPPLY TO THE PATIENT WILL CEASE. ELIMINATE THE CAUSE OF THE PUMP STOP AND START THE PUMP AGAIN AS SOON AS POSSIBLE. 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. NOTE: THIS EVENT OCCURRED ON THE SOUTH KOREA 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 701043290.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN SOUTH KOREA. IT WAS REPORTED THAT ON (B)(6) 2026 THE ROTAFLOW CONSOLE IN THE CCU (CORONARY CARE UNIT) WAS SHUTTING OFF DURING PATIENT TREATMENT. ON 2026-05-04 THE GETINGE FIELD SERVICE TECHNICIAN INVESTIGATED THE DEVICE, AND THE ON/OFF SWITCH WAS IDENTIFIED AS FAULTY. NO HARM TO ANY PERSON HAS BEEN REPORTED. ON 2026-05-11 THE SSU (SALES AND SERVICE UNIT) PROVIDED NEW INFORMATION AS FOLLOWS: WHEN THE EVENT OCCURRED, THE DEFECTIVE DEVICE WAS REPLACED WITH ANOTHER UNIT. THE DEVICE SHUT DOWN WITHOUT ANY MESSAGE DUE TO THE DEFECTIVE ON/OFF SWITCH. SINCE THE ENGINEER IDENTIFIED THAT THE ON/OFF SWITCH COULD NOT REMAIN FIXED IN THE ON POSITION, IT APPEARS THAT THE SWITCH MOVED TO THE OFF POSITION WHEN THE SHUTDOWN OCCURRED. DUE TO THE REPORTED SHUTDOWN DURING PATIENT USE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447283 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706037#ROTAFLOW ENGLISH EU-PLUG 04037691525532

    Patients

    Seq Age Sex Outcome Treatment
    1