BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 22712194 · Received August 5, 2025

    Report

    Report Number
    8010762-2025-0000332
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 19, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    UDI-DI
    04037691562445
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 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 701043292.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT THE ERROR MESSAGE ¿SIG ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE. THE RPMS WERE VISIBLE BUT ON THE FLOW SCREEN JUST DASHES ¿---¿ WERE DISPLAYED. THE CONTACT CREAM WAS REAPPLIED BUT THE DEVICE COULD NOT BE REZEROED AND THE HAND CRANK WAS USED. THE DEVICE WAS IMMEDIATELY EXCHANGED WITH A BACKUP DEVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE REPORTED EXCHANGE OF THE DEVICE DURING PATIENT TREATMENT A REPORT IS REQUIRED. THE PATIENT DATA WAS NOT SHARED BY CUSTOMER. THE AFFECTED ROTAFLOW CONSOLE WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN. THE REPORTED FAILURES "SIG ERROR", "NO FLOW RATE DISPLAYED" AND "DEVICE COULD NOT BE RE-ZEROED" COULD NOT BE CONFIRMED. THE RESET WAS PERFORMED BY THE GETINGE FIELD SERVICE TECHNICIAN AND IT WAS OBSERVED THAT THE DEVICE'S RESET WORKED. THE ROTAFLOW DRIVE WAS FOUND TO BE DIRTY AND WAS CLEANED. NO PARTS HAVE BEEN REPLACED. THE DEVICE WAS WORKING AS INTENDED AND CAN BE USED CLINICALLY. BASED IN THE INFORMATION AVAILABLE AT THIS TIME THE REPORTED FAILURES COULD NOT BE CONFIRMED. HOWEVER, THE FAILURE MODE "SIG ERROR" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO THE ROTAFLOW RISK MANAGEMENT FILE (DMS# (B)(4)): - MECHANICAL DEFECTS (IMPACT) - EXPECTED WEAR AND TEAR. THE FAILURE MODE "NO FLOW RATE DISPLAYED" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO THE ROTAFLOW RISK MANAGEMENT FILE: - WRONG INTERVENTION LIMITS - ZERO FLOW CALIBRATION FAILED - INCORRECT FLOW MEASUREMENT. THE FAILURE MODE "DEVICE COULD NOT BE RE-ZEROED" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO OUR RISK MANAGEMENT FILE (DMS# (B)(4)): INCORRECT FLOW MEASUREMENT - DEVICE USED OUT OF SPECIFICATION - SOFTWARE ERROR - INTERNAL CPU FAILURE - NON-VOLATILE MEMORY FAILURE - VOLATILE MEMORY FAILURE - FAILURE IN SAFETY RELEVANT VARIABLES - WATCHDOG FAILURE - TIME BASE FAILURE - FAILURE OF INTERNAL COMPONENTS (ADC, ETC.). THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2025-08-04 AND DURING THE PERIOD OF 2016-12-07 TO 2025-07-24 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 AFFECTED ROTAFLOW DEVICE WAS PRODUCED IN 2016-12-07. 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 CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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 THE US. IT WAS REPORTED THAT THE ERROR MESSAGE ¿SIG ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE. THERE WAS NO PUMP STOP. THE RPMS WERE VISIBLE BUT ON THE FLOW SCREEN JUST DASHES ¿---¿ WERE DISPLAYED. THE CONTACT CREAM WAS REAPPLIED AND THE HAND CRANK WAS USED. THE DEVICE WAS IMMEDIATELY EXCHANGED WITH A BACKUP DEVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE REPORTED EXCHANGE OF THE DEVICE DURING PATIENT TREATMENT 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
    2804114 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706035#ROTAFLOW ENGLISH/US US-PLUG 04037691562445

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention