BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 24596827 · Received March 13, 2026

    Report

    Report Number
    8010762-2026-0000116
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Report Date
    April 1, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    UDI-DI
    04037691525532
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED SOLELY TO PROVIDE THE MISSING PATIENT INFORMATION (SECTION A), WHICH WAS RECEIVED ON 2026-03-16; THE INVESTIGATION RESULTS AND CONCLUSIONS REMAIN UNCHANGED FROM THE PREVIOUS SUBMISSION.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN SOUTH KOREA. IT WAS REPORTED THAT AN ALARM SOUNDED ON THE ROTAFLOW AND THE RPM DROPPED TO 0 DURING PATIENT TREATMENT. THE EMERGENCY DRIVE HAD TO BE USED, AND THE DEVICE WAS REBOOTED. DESPITE REBOOTING THE DEVICE THE LPM WAS NOT MEASURED THEREFORE, THE ROTAFLOW WAS REPLACED TO CONTINUE TREATMENT, WITHOUT ANY NEGATIVE CONSEQUENCES FOR THE PATIENT. 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. THE AFFECTED ROTAFLOW CONSOLE WITH S/N (B)(6) WAS INVESTIGATED BY A SERVICE ENGINEER AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. DURING THE INSPECTION OF THE DEVICE THE TECHNICIAN APPLIED SUFFICIENT CONTACT CREAM AND THE FLOW MEASUREMENT FUNCTIONS WERE CONFIRMED TO BE OPERATING PROPERLY. NO PARTS HAVE BEEN REPLACED. THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE COULD BE DETERMINED BY THE DISTRIBUTOR AND WAS NOT CONSIDERED TO BE A DEVICE FAULT, IT WAS DUE TO INSUFFICIENT CONTACT CREAM IN THE DRIVE. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2026-02-25 FOR THE PERIOD OF 2020-02-04 TO 2026-02-24. IT 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 DEVICE WAS PRODUCED IN 2020-02-04. 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 NUMBER WITHIN THE TIMEFRAME OF THE SEARCH NO ADDITIONAL COMPLAINT WAS FOUND FOR THE SAME ISSUE. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE, IT IS NECCESSARY TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / V15. CHAPTER 5.1: APPLY ULTRASONIC CONTACT CREAM TO BOTH SIDES (LEFT AND RIGHT) AROUND THE OUTLET OF THE ROTAFLOW CENTRIFUGAL PUMP. BOTH SIDES MUST BE COMPLETELY COVERED WITH THE ULTRASONIC CONTACT CREAM. CHAPTER 6.2: THE ULTRASONIC CONTACT CREAM CAN DRY OUT AND IMPAIR THE FUNCTIONING OF THE INTEGRATED FLOW/BUBBLE SENSOR. IN THE "FREE" MODE, THE ULTRASONIC CONTACT CREAM MUST BE REAPPLIED EVERY 48 HOURS OR AS SOON AS THE ERROR MESSAGE [SIG!] APPEARS. IN THE "STAND AL" MODE, THE ULTRASONIC CONTACT CREAM MUST BE REAPPLIED EVERY 48 HOURS OR AS SOON AS THE ERROR MESSAGE [FAULTBUB] APPEARS. COMPLETE REAPPLICATION IN LESS THAN 60 SECONDS. 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 KOREAN 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

    COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN SOUTH KOREA. IT WAS REPORTED THAT AN ALARM SOUNDED ON THE ROTAFLOW AND THE RPM DROPPED TO 0 DURING PATIENT TREATMENT. THE EMERGENCY DRIVE HAD TO BE USED, AND THE DEVICE WAS REBOOTED. DESPITE REBOOTING THE DEVICE THE LPM WAS NOT MEASURED THEREFORE, THE ROTAFLOW WAS REPLACED TO CONTINUE TREATMENT, WITHOUT ANY NEGATIVE CONSEQUENCES FOR THE PATIENT. 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653415 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 63 YR Male