BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 19962248 · Received August 12, 2024

    Report

    Report Number
    8010762-2024-00400
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    August 8, 2024
    Report Date
    August 28, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    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

    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.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN SOUTH KOREA. IT WAS REPORTED THAT THE ERROR MESSAGE "HEAD ERROR" OCCURRED WHEN THE CUSTOMER INCREASED THE RPM (REVOLUTIONS PER MINUTE) OVER 1000 DURING PRIMING. THE DEVICE WAS NOT USED FOR PATIENT TREATMENT, ANOTHER DEVICE WAS USED. UPON INSPECTION OF THE DEVICE, THE CONTROL BOARD ON THE ROTAFLOW CONSOLE AND THE ROTAFLOW DRIVE WERE DETECTED AS DEFECTIVE. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP DURING TREATMENT THEREFORE, A REPORT IS REQUIRED. THE ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6) AND THE ROTAFLOW DRIVE (RFD) WITH S/N (B)(6) WERE INVESTIGATED BY A GETINGE SERVICE TECHNICIAN AND THE "HEAD ERROR" COULD BE CONFIRMED. THE MCP00705057#RFC CONTROL BOARD KIT (ARTICLE NUMBER 701034051) HAS BEEN REPLACED ON THE ROTAFLOW CONSOLE. AFTER THE REPLACEMENT THE RFC IS WORKING AS INTENDED. FURTHERMORE, THE ROTAFLOW DRIVE (RFD) WITH S/N (B)(6) WAS ALSO DETECTED AS DEFECTIVE. THE ROTAFLOW DRIVE (RFD) WITH S/N (B)(6) WAS SENT BACK TO MANUFACTURER FOR REPAIR. DURING THE INVESTIGATION BY THE GETINGE SERVICE DEPARTMENT ON 2024-08-28 THE REPORTED "HEAD ERROR" COULD BE REPRODUCED. THUS, THE DRIVE HAS BEEN SEND TO THE SUPPLIER EMTEC FOR REPAIR. THE FOLLOWING MOST POSSIBLE ROOT CAUSE COULD BE DETERMINED FOR THE HEAD ERROR: THE HEAD ERROR IS CAUSED BY THE HOT PLUG. WHEN THE DEVICE IS IN OPERATION AND THE POWER PLUG IS PLUGGED IN OR OUT THE HEAD ERROR OCCURS AND THE ROTA FLOW DRIVE AND / OR THE CONTROL BOARD IS DAMAGED. AS A RESULT, THE ROTA FLOW DRIVE AND / OR THE CONTROL BOARD HAS TO BE REPLACED. BASED ON THESE INVESTIGATION RESULTS THE REPORTED "HEAD ERROR" COULD BE CONFIRMED. ROTAFLOW CONSOLE: THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2024-08-12 AND DURING THE PERIOD OF 2021-09-27 TO 2024-08-08 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 CONSOLE WITH S/N (B)(6) WAS PRODUCED IN 2021-09-27. ROTAFLOW DRIVE: THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2024-08-12 AND DURING THE PERIOD OF 2021-09-27 TO 2024-08-08 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 DRIVE WITH S/N (B)(6) WAS PRODUCED IN 2021-09-27. 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, THE CUSTOMER WILL BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / 15. CHAPTER 4.1.3: SWITCH OFF THE ROTAFLOW CONSOLE ON/OFF SWITCH BEFORE CONNECTING THE ROTAFLOW DRIVE TO OR DISCONNECTING IT FROM THE ROTAFLOW CONSOLE. OTHERWISE, THE ROTAFLOW CONSOLE MAY BE DAMAGED. 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 SOUTH KOREA. IT WAS REPORTED THAT THE ERROR MESSAGE "HEAD ERROR" OCCURRED IF THE CUSTOMER INCREASED THE RPM (REVOLUTIONS PER MINUTE) OVER 1000 DURING PRIMING. THE DEVICE WAS NOT USED ANOTHER DEVICE WAS USED FOR TREATMENT. UPON INSPECTION THE DEVICE THE CONTROL BOARD ON THE ROTAFLOW CONSOLE AND THE ROTAFLOW DRIVE WAS DETECTED AS DEFECTIVE. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP DURING TREATMENT 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
    2293599 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW ENGLISH EU-PLUG ICU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown