BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 20542476 · Received October 28, 2024

    Report

    Report Number
    8010762-2024-0000511
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 22, 2024
    Report Date
    January 24, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 E4.1 (NO MALFUNCTION ¿ E.4.1 INDICATES THE SOFTWARE VERSION) AND THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE DURING START UP. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP DURING TREATMENT THERFORE, A REPORT IS REQUIRED. THE AFFECTED ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6) AND THE ROTAFLOW DRIVE (RFD) WITH S/N (B)(6) WAS INVESTIGATED BY THE GETINGE FIELD SERVICE TECHNICIAN AND THE "HEAD ERROR" COULD BE CONFIRMED. THE RFC CONTROL BOARD KIT (ARTICLE NUMBER 70103.4051) HAS BEEN REPLACED IN THE RFC. AS PART OF THE REGULAR TWO YEAR SERVICE THE BATTERYPACK NI-CD 24V 132WH (RFC) (ARTICLE NUMBER 701017188) HAS ALSO BEEN REPLACED ON THE RFC. AFTER THE REPLACEMENT THE ROTAFLOW CONSOLE IS WORKING AS INTENDED. THE RFD NEEDS TO BE REPAIRED BY THE SUPPLIER. 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 2024-11-20 THE REPORTED "HEAD ERROR" COULD BE REPRODUCED. THUS, THE DRIVE WAS SENT TO THE SUPPLIER EMTEC FOR REPAIR. ON 2024-12-05 THE SUPPLIER EMTEC WAS ABLE TO REPRODUCE THE REPORTED FAILURE "HEAD ERROR" AND THE ROOT CAUSE COULD BE DETERMINED AS MISUSE OF THE DEVICE, WHICH LEAD TO A DAMAGE OF THE ELECTRONIC PARTS. THESE PARTS WERE REPLACED BY THE SUPPLIER. AFTER FUNCTIONAL TEST AT THE GETINGE SERVICE DEPARTMENT ON 2024-12-13 THE DEVICE WAS SENT BACK TO THE USER. 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 FAILURE "HEAD ERROR" COULD BE CONFIRMED. ROTAFLOW CONSOLE: THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2024-10-25 FOR THE PERIOD OF 2011-08-23 TO 2024-10-22. IT SHOWS NON-CONFORMITIES IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THE COMPLAINT INFORMATION WAS TRANSFERRED TO THE INTERNAL NONCONFORMITY PROCESS. THE ROTAFLOW CONSOLE WITH S/N (B)(6) WAS PRODUCED IN 2011-08-23. ROTAFLOW DRIVE: THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2024-10-25 AND DURING THE PERIOD OF 2018-03-20 TO 2024-10-22 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 2018-03-20. 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 NUMBERS 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.

    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: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THIS MACHINE (ROTAFLOW CONSOLE) HAS BEEN MANUFACTURED ON 2011. ALL MAQUET CARDIOPULMONARY CLASS II PRODUCTS MANUFACTURED UNTIL 2015 DO NOT HAVE UDI ENTRIES. THEREFORE, NO UDI NUMBER IS AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT E4.1 (NO MALFUNCTION ¿ E.4.1 INDICATES THE SOFTWARE VERSION) AND THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE DURING START UP. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED ¿HEAD ERROR¿ COULD LEAD TO THE PUMP STOP DURING TREATMENT THERFORE, A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725574 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706035#ROTAFLOW ENGLISH/US US-PLUG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown