BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART LUNG MACHINE

    MDR report key: 19296117 · Received May 13, 2024

    Report

    Report Number
    8010762-2024-00267
    Event Type
    Death
    Date Received
    May 13, 2024
    Date of Event
    May 7, 2024
    Report Date
    February 7, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN FRANCE. IT WAS REPORTED THAT THE ROTAFLOW CONSOLE SHUT DOWN AFTER TRANSPORT. THE PATIENT PASSED AWAY IN THE MED UNIT. THE FOLLOWING WAS REPORTED: ¿BATTERY PROBLEM DURING TRANSPORT, AND THE ROTAFLOW CONSOLE WITH S/N (B)(6) WAS TURNED OFF. THE PATIENT HAD SEVERAL EXAMINATIONS. DURING THESE EXAMINATIONS, THERE WERE SEVERAL BATTERY TRANSPORTS (REA SCANNER, SCANNER BLOCK, BLOCK REA). BETWEEN THESE EXAMINATIONS, THE USER RECONNECTED THE ROTAFLOW TO THE MAINS (AC POWER). THE ROTAFLOW CONSOLE STOPPED WHEN THE PATIENT WAS IN THE ROOM. WHEN THE GETINGE FIELD SERVICE TECHNICIAN WAS ON SITE AND PLUGGED THE ROTAFLOW CONSOLE IN, IT WAS NOTICED THAT THE SWITCH WAS ¿OFF¿ AND THEREFORE THE BATTERY WAS NO LONGER CHARGING. THE LED´S WERE ALSO OFF. TECHNICIAN TURNED THE SWITCH TO ¿ON¿ AND THE BATTERY WAS CHARGING AGAIN. THE BATTERY SHOWED 26.6V. THE TECHNICIAN DID NOT NOTICE ANY ANOMALY WITH THE BATTERY. THE BATTERY HAS REPLACED AS A PRECAUTION. FURTHERMORE, IT WAS NOTICED BY THE TECHNICIAN DURING THE SERVICE THAT THE SN (B)(6) ISOLATION TRANSFORMER (PART OF THE SPRINTER CART) WAS NO LONGER SUPPLYING THE HU35 + ROTAFLOW SYSTEM. THE FUSES WERE CHANGED, AND THE TRANSFORMER IS STILL UNUSABLE. IT IS PLANNED TO CHANGE THE ISOLATION TRANSFORMER. FOLLOWING THE BREAKDOWN OF THE ISOLATION TRANSFORMER, THE SYSTEM CAN ONLY BE USED PARTIALLY AND THEREFORE NOT COMPLIANT. THE AFFECTED SPRINTER CART WILL BE HANDLE IN COMPLAINT (B)(4), WHICH IS NOT A REPORTABLE EVENT. CONFIRMED BY GETINGE FIELD SERVICE TECHNICIAN DATED ON 2024-07-18 THE ROTAFLOW CONSOLE WAS NOT CONNECTED TO THE SPRINTER CART AT TIME OF THE EVENT AND THE CUSTOMER WAS AWARE THAT THE SPRINTER CART WAS NON FUNCTIONAL. THE AFFECTED ROTAFLOW CONSOLE WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND THE REPORTED FAILURE COULD NOT BE DUPLICATED. DURING THE INVESTIGATION BY THE GETINGE FIELD SERVICE TECHNICIAN WHEN THE ROTAFLOW CONSOLE WAS PLUGGED IN, IT WAS NOTICED THAT THE SWITCH WAS IN THE ¿OFF¿ POSITION AND THEREFORE THE BATTERY WAS NO LONGER CHARGING. THE LED´S WERE ALSO OFF. TECHNICIAN TURNED THE SWITCH TO ¿ON¿ AND THE BATTERY WAS CHARGING AGAIN. THE BATTERY SHOWED 26.6V. THE TECHNICIAN DID NOT NOTICE ANY ANOMALY WITH THE BATTERY. THE (B)(6) #BATTERY PACK FOR RFC (ARTICLE NUMBER (B)(4)) HAS REPLACED AS A PRECAUTION. AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. THE AFFECTED MCP00702755#BATTERY PACK FOR ROTAFLOW CONSOLE (RFC) WAS INVESTIGATED BY THE GETINGE LIFE-CYCLE-ENGINEERING (LCE) WITH THE FOLLOWING OUTCOME: DURING THE INVESTIGATION, THREE DEFECTIVE BATTERY CELLS WERE IDENTIFIED. THIS RESULTS IN EXCESSIVE WARMING OF THE BACKUP BATTERY DURING CHARGING AND INCOMPLETE CHARGING DUE TO OVER-TEMPERATURE PROTECTION. THEREFORE, THE BACKUP BATTERY WILL NOT BE FULLY CHARGED WITH A RESULTING BATTERY RUN-TIME OF ONLY ABOUT 55 MINUTES. HOWEVER, A DEFECTIVE BATTERY IS NOT A POSSIBLE CAUSE FOR SHUT DOWN OF THE RFC IF IT IS RUNNING ON MAINS POWER WITH THE MAINS CIRCUIT BREAKER IN THE "ON" POSITION. POSSIBLE ROOT CAUSES FOR AN UNINTENDED SHUT DOWN OF THE RFC WHILE IT WAS CONNECTED TO MAINS POWER COULD BE: - CONNECTED TO AN ACTIVE MAINS OUTLET BUT THE MAINS CIRCUIT BREAKER WAS IN THE OFF POSITION. - DEFECTIVE ON/OFF SWITCH ON THE FRONT OF THE RFC. THE MOST PROBABLE ROOT CAUSE FOR THE DEFECTIVE BATTERY CELLS IS DEEP DISCHARGE. THE BACKUP BATTERY MUST BE RECHARGED AFTER RUNNING ON BATTERY AND DURING STORAGE. AT THIS TIME THE RFC MUST BE CONNECTED TO AN ACTIVE MAINS OUTLET AND THE MAINS CIRCUIT BREAKER HAS TO BE IN THE "ON" POSITION. OTHERWISE, THE BATTERY CELLS CAN GET DAMAGED BY DEEP SELF-DISCHARGE. IT CANNOT BE DETERMINED IF THE BATTERY WAS ALREADY DAMAGED DURING THE EVENT AND SUBSEQUENT INSPECTION BY THE SERVICE TECHNICIAN OR IF IT HAPPENED DURING TO THE LONG TRANSPORT TIME OF 7 MONTHS UNTIL THIS INVESTIGATION. A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON (B)(6) 2025 WITH FOLLOWING CONCLUSION: "AN INCIDENT OCCURRED ON (B)(6) 2024 IN (B)(6), WHERE THE RFC SHUT DOWN FOLLOWING TRANSPORT, AND THE PATIENT EXPIRED IN THE MEDICAL UNIT. THE PATIENT UNDERWENT SEVERAL EXAMINATIONS, DURING WHICH THE RFC WAS TRANSPORTED MULTIPLE TIMES ON BATTERY POWER AND RECONNECTED TO MAINS POWER IN BETWEEN. DESPITE THIS, THE RFC POWERED DOWN WHILE THE PATIENT REMAINED IN THE ROOM. UPON INSPECTION BY THE GETINGE FIELD SERVICE TECHNICIAN, THE POWER SWITCH WAS FOUND IN THE "OFF" POSITION, PREVENTING THE BATTERY FROM CHARGING. AFTER TURNING THE SWITCH TO "ON," THE BATTERY RESUMED CHARGING AND SHOWED 26.6V. THE BATTERY WAS REPLACED AS A PRECAUTION. THE TECHNICIAN ALSO DISCOVERED A DEFECTIVE ISOLATION TRANSFORMER IN THE SPRINTERCART, WHICH WAS NO LONGER SUPPLYING POWER TO THE SYSTEM. DESPITE REPLACING THE FUSES, THE TRANSFORMER REMAINED INOPERATIVE, AND A REPLACEMENT HAS BEEN SCHEDULED. AS A RESULT, THE SYSTEM COULD ONLY OPERATE PARTIALLY AND DID NOT MEET COMPLIANCE STANDARDS. THE LCE INVESTIGATION IDENTIFIED THREE FAULTY BATTERY CELLS, LEADING TO EXCESSIVE HEATING AND INCOMPLETE CHARGING, PROVIDING ONLY 55 MINUTES OF RUNTIME. HOWEVER, A DEFECTIVE BATTERY IS NOT CONSIDERED A CAUSE FOR THE RFC SHUTDOWN WHEN CONNECTED TO MAINS POWER, ASSUMING THE MAINS CIRCUIT BREAKER IS IN THE "ON" POSITION. POTENTIAL ROOT CAUSES FOR THE SHUTDOWN WHILE CONNECTED TO MAINS POWER INCLUDE AN ACTIVE MAINS OUTLET WITH THE CIRCUIT BREAKER IN THE "OFF" POSITION, OR A MALFUNCTIONING ON/OFF SWITCH. THE MOST LIKELY CAUSE OF THE FAULTY BATTERY CELLS IS DEEP DISCHARGE, WHICH CAN OCCUR IF THE BACKUP BATTERY IS NOT RECHARGED PROPERLY. IT REMAINS UNCLEAR WHETHER THE BATTERY DAMAGE OCCURRED DURING THE INCIDENT OR DUE TO THE PROLONGED SEVEN-MONTH TRANSPORT TIME. IT IS IMPORTANT TO MENTION THAT A QUESTIONNAIRE WAS SENT TO THE AFFECTED CUSTOMER TO GATHER INFORMATION REGARDING THE INCIDENT AND THE PATIENT. HOWEVER, DESPITE SEVERAL GFES, THE QUESTIONNAIRE HAS NOT BEEN COMPLETED, AND AS A RESULT, NO FURTHER DETAILS ABOUT THE INCIDENT OR THE PATIENT ARE AVAILABLE. IN CONCLUSION, THE AVAILABLE INFORMATION, AND THE COMPONENTS AVAILABLE FOR INVESTIGATION DO NOT PROVIDE ENOUGH CLARITY TO DETERMINE A ROOT CAUSE FOR THE UNINTENDED SHUTDOWN OF THE RFC WHEN CONNECTED TO MAINS POWER. THERE IS INSUFFICIENT DATA TO IDENTIFY THE ROOT CAUSE OF THE UNEXPECTED SHUTDOWN. HOWEVER, THE LCE REPORT INDICATES THAT THE MOST LIKELY CAUSE FOR THE DEFECTIVE BATTERY IS DEEP DISCHARGE, WHICH MAY HAVE OCCURRED DUE TO IMPROPER CHARGING OR DURING TRANSPORT TO THE MPC LABORATORY. IT SHOULD BE NOTED, HOWEVER, THAT THE RFC ISSUES TWO HIGH-PRIORITY ALARMS IN THE EVENT OF A LOW BATTERY STATUS, DEPENDING ON THE VOLTAGE STATUS OF THE BATTERIES. ADDITIONALLY, THE IFU STATES THAT AFTER CONNECTING TO THE MAIN POWER SUPPLY, IT MUST BE ENSURED THAT THE 'BATTERY CHARGING LAMP LIGHTS UP DURING CHARGING. FURTHERMORE, IT SHOULD BE NOTED THAT THE RFC CAN BE MANUALLY OPERATED USING AN EMERGENCY DRIVE IN THE EVENT OF A PUMP STOP, REGARDLESS OF THE CAUSE. THE IFU ALSO SPECIFIES THAT THE POSITIONING OF THE EMERGENCY DRIVE SHOULD BE CHOSEN BY THE USER TO ENSURE THAT ¿YOU (CAN ENSURE) (...) TO SWAP THE ROTAFLOW CENTRIFUGAL PUMP FROM THE ROTAFLOW DRIVE TO THE ROTAFLOW EMERGENCY DRIVE QUICKLY IN AN EMERGENCY". FURTHERMORE, IT IS DIFFICULT TO ASSESS WHETHER THE REPORTED INCIDENT DIRECTLY INFLUENCED THE PATIENT'S OUTCOME, AS NO FURTHER DETAILS REGARDING THE PATIENT'S CONDITION OR CONTRIBUTING FACTORS ARE AVAILABLE. HOWEVER, THE SHUTDOWN OF THE RFC, WHICH RESULTED IN A PUMP STOP, MAY HAVE CONTRIBUTED TO THE PATIENT'S OVERALL DETERIORATION. WITHOUT ADDITIONAL INFORMATION SURROUNDING THE INCIDENT, IT IS CHALLENGING TO DEFINITIVELY ATTRIBUTE THE EVENT TO EITHER A REDUCTION IN PERFORMANCE OR A MALFUNCTION OF THE PRODUCT. BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2024-05-08 AND DURING THE PERIOD OF 2017-11-17 TO 2024-05-07 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 WAS PRODUCED IN 2017-11-17. 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. 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 2.2.4 GENERAL PRECAUTIONARY MEASURES DURING USE IF THE PUMP STOPS DURING AN APPLICATION, THE BLOOD FLOW WILL BE INTERRUPTED AND SUPPLY TO THE PATIENT WILL CEASE. ELIMINATE THE CAUSE OF THE PUMP STOP AND START THE PUMP AGAIN AS SOON AS POSSIBLE. 2.2 GENERAL SAFETY INSTRUCTION THERE IS THE RISK THAT ACOUSTIC ALARMS EMITTED BY THE ROTAFLOW SYSTEM MAY NOT BE HEARD. YOU SHOULD THEREFORE POSITION THE SYSTEM SO THAT YOU CAN SEE THE DISPLAYS ON THE ROTAFLOW CONSOLE AND ANY OPTICAL WARNING SIGNALS AT ALL TIMES. 3.3.4 BATTERY OPERATION "STATUS OF THE POWER SUPPLY DURING BATTERY OPERATION" THE ACOUSTIC ALARM CAN BE SWITCHED OFF WITH THE "AUDIO OFF" BUTTON. 2.2.4 GENERAL PRECAUTIONARY MEASURES DURING USE ALWAYS KEEP THE ROTAFLOW EMERGENCY DRIVE AT THE READY FOR STOP-GAP MANUAL OPERATION IN THE EVENT OF PUMP DRIVE FAILURE. 2.2.2 POSITION OF USE AND OPERATION, AND POSITIONING ENSURE THAT THERE IS SUFFICIENT ROOM TO USE THE HAND CRANK OF THE ROTAFLOW EMERGENCY DRIVE. 4.1.4 POSITIONING THE ROTAFLOW EMERGENCY DRIVE THE ROTAFLOW EMERGENCY DRIVE CAN BE USED TO DRIVE THE ROTAFLOW CENTRIFUGAL PUMP MANUALLY IF THE ROTAFLOW CONSOLE OR THE ROTAFLOW DRIVE FAIL. FIT THE ROTAFLOW EMERGENCY DRIVE NEAR THE ROTAFLOW DRIVE. ENSURE YOU WILL BE ABLE TO SWAP THE ROTAFLOW CENTRIFUGAL PUMP FROM THE ROTAFLOW DRIVE TO THE ROTAFLOW EMERGENCY DRIVE QUICKLY IN AN EMERGENCY. 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. NOTE: THIS EVENT OCCURRED ON THE GERMAN MARKET ON A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, ROTAFLOW", WHICH IS SOLD IN THE US. FOR D4 UNIQUE IDENTIFIER (UDI)#, PRIMARY DI NUMBER HAS BEEN USED FOR BASE UNIT, ROTAFLOW WITH CATALOG NUMBER 701051699. PROVIDED D4 SERIAL NUMBER AND H4 DEVICE MANUFACTURER DATE CORRESPOND TO DEVICE INVOLVED IN THE EVENT, NOT AVAILABLE IN US.

    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 FRANCE. IT WAS REPORTED THAT THE ROTAFLOW CONSOLE SHUT DOWN AFTER TRANSPORT. THE PATIENT EXPIRED IN THE MED UNIT. THE FOLLOWING WAS REPORTED: ¿BATTERY PROBLEM DURING TRANSPORT, AND THE ROTAFLOW CONSOLE WITH S/N (B)(6) WAS TURNED OFF. THE PATIENT HAD SEVERAL EXAMINATIONS. DURING THESE EXAMINATIONS, THERE WERE SEVERAL BATTERY TRANSPORTS (REA SCANNER, SCANNER BLOCK, BLOCK REA). BETWEEN THESE EXAMINATIONS, THE USER RECONNECTED THE ROTAFLOW TO THE MAINS (AC POWER). THE ROTAFLOW CONSOLE STOPPED WHEN THE PATIENT WAS IN THE ROOM. WHEN THE GETINGE FIELD SERVICE TECHNICIAN WAS ON SITE AND PLUGGED THE ROTAFLOW CONSOLE IN, IT WAS NOTICED THAT THE SWITCH WAS ¿OFF¿ AND THEREFORE THE BATTERY WAS NO LONGER CHARGING. THE LED´S WERE ALSO OFF. COMPLAINT ID: (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449286 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW FRENCH EU-PLUG ICU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death