BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 16730879 · Received April 13, 2023

    Report

    Report Number
    8010762-2023-00176
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    December 7, 2022
    Report Date
    August 15, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 "TXRX ERROR" OCCURRED ON THE ROTAFLOW CONSOLE (RFC). IT IS UNKNOWN WHEN THE REPORTED "TXRX ERROR" OCCURRED. FURTHERMORE, DURING TESTING THE RFC, THE ERROR MESSAGE ¿HEAD ERROR¿ WAS DISPLAYED. NO HARM TO ANY PERSON HAS BEEN REPORTED. A GETINGE FIELD SERVICE TECHNICIAN INVESTIGATED THE AFFECTED ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6) AND THE ROTAFLOW DRIVE (RFD) WITH S/N (B)(6). THE TECHNICIAN WAS UNABLE TO CONFIRM THE REPORTED "TXRX ERROR". HOWEVER, THE RFD WAS DETECTED AS DEFECTIVE WHICH LEAD TO THE REPORTED "HEAD ERROR". NO PARTS HAS BEEN REPLACED ON THE RFC. THE RFC IS WOKING AS INTENDED. 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 2023-07-03 THE REPORTED "HEAD ERROR" COULD BE REPRODUCED. THUS, THE DRIVE WAS SENT TO THE SUPPLIER EMTEC FOR REPAIR. ON 2023-08-08 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 2023-08-14 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 "TXRX" COULD NOT BE CONFIRMED. HOWEVER, THE OCCURRED "HEAD ERROR" DURING THE INVESTIGATION COULD BE CONFIRMED. HOWEVER, THE FAILURE MODE "TXRX" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO THE ROTAFLOW RISK MANAGEMENT FILE. MALFUNCTION OF THE MICROCOMPUTER SYSTEM: 1. INTERNAL CPU FAILURE 2. NON-VOLATILE MEMORY FAILURE 3. VOLATILE MEMORY FAILURE 4. FAILURE IN SAFETY RELEVANT VARIABLES 5. WATCHDOG FAILURE 6. TIME BASE FAILURE 7. FAILURE ON OTHER DEVICE PARTS (ROTARY KNOB, DISPLAY, ETC) 8. FAILURE OF INTERNAL COMPONENTS (ADC, ETC.) ROTAFLOW CONSOLE: THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2022-12-09 AND DURING THE PERIOD OF 2015-07-01 TO 2022-12-09 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 CONSOLE IN QUESTION WAS PRODUCED IN 2015-07-01. ROTAFLOW DRIVE: THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2023-08-15 AND DURING THE PERIOD OF 2010-11-25 TO 2023-08-15 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 DRIVE IN QUESTION WAS PRODUCED IN 2010-11-25. 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 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.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN THE US. IT WAS INITIALLY REPORTED THAT THE "TXRX ERROR" OCCURRED ON THE ROTAFLOW CONSOLE. DURING START UP BY TESTING THE DEVICE BY THE GETINGE FIELD SERVICE TECHNICIAN THE ERROR MESSAGE "HEAD ERROR" OCCURRED ON THE ROTAFLOW DRIVE. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979161 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW ENGLISH/US US-PLUG ICU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown