BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 19699112 · Received July 9, 2024

    Report

    Report Number
    8010762-2024-00348
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 9, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT THE ERROR MESSAGE [FAULTLEV] OCCURRED ON THE ROTAFLOW CONSOLE AND THE FLOW STOPPED (0 RPM (REVOLUTIONS PER MINUTE) DURING PATIENT USE. THE DEVICE WAS EXCHANGED WITH ANOTHER DEVICE WITH NO CONSEQUENCES FOR THE PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. BASED ON THE INFORMATION THAT THE FLOW HAS STOPPED, A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN INVESTIGATED THE ROTAFLOW CONSOLE WITH S/N (B)(6) AND THE REPORTED ERROR [FAULTLEV] COULD NOT BE REPRODUCED. AS A PRECAUTION THE RF FLOW MEASURE PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) (ARTICLE NUMBER 701011681) HAS BEEN REPLACED. THE DEVICE IS WORKING AS INTENDED AND IS BACK IN USE. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE "[FAULTLEV] ERROR" COULD NOT BE CONFIRMED. HOWEVER, THE REPORTED FAILURE WAS INVESTIGATED IN A PREVIOUS COMPLAINT IN THE GETINGE LIFE CYCLE ENGINEERING (LCE) AND THE MOST PROBABLE ROOT CAUSE COULD BE DETERMINED AS A MECHANICAL DEFECT OF THE SHUNT R48. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2024-06-28 AND DURING THE PERIOD OF 2004-04-30 TO 2024-06-27 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 COSOLE WITH S/N (B)(6) WAS PRODUCED IN 2004-04-30. 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 [FAULTLEV] OCCURRED ON THE ROTAFLOW CONSOLE AND THE FLOW STOPPED (0 RPM (REVOLUTIONS PER MINUTE) DURING PATIENT USE. THE DEVICE WAS EXCHANGED WITH ANOTHER DEVICE WITH NO CONSEQUENCES FOR THE PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. BASED ON THE INFORMATION THAT THE FLOW HAS STOPPED; A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257035 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH RFC 20-970 / ROTAFLOW CON

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention