HEART LUNG MACHINE
Report
- Report Number
- 8010762-2024-00367
- Event Type
- Death
- Date Received
- July 23, 2024
- Date of Event
- July 13, 2024
- Report Date
- September 19, 2024
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE EVENT OCCURRED IN CHINA. IT WAS INITIALLY REPORTED THAT THE DISPLAY ON THE ROTAFLOW CONSOLE WENT BLACK DURING PATIENT USE. THE EMERGENCY HAND CRANK WAS USED. DUE TO THE DEATH OF THE PATIENT A REPORT IS REQUIRED. ON 2024-07-19 GETINGE SSU (SALES AND SERVICE) INFORMED US THAT THE PATIENT PASSED AWAY. ON 2024-07-26 GETINGE SSU INFORMED US AS FOLLOWS: "ACCORDING TO THE CUSTOMER, THE PATIENT'S HEART HAD STOPPED BEATING IN THE AMBULANCE ON THE WAY TO THE HOSPITAL. AFTER THE PATIENT ARRIVED AT THE HOSPITAL, THE DOCTOR DECIDED TO USE ROTAFLOW FOR TREATMENT. AFTER PRIMING THE PLS SET, AND DECIDE TO CONNECT THE PLS WITH CANNULA, THE DEVICE SCREEN WAS BLACK, AND THE PUMP STOPPED, THE DOCTOR USED A HAND CRANK. DOCTOR CONTINUE USE THE HAND CRANK (ABOUT 2 HOURS) UNTIL THE HOSPITAL BORROWED ANOTHER ROTAFLOW (S/N (B)(6)) FROM THE HANGZHOU RED CROSS HOSPITAL TO CONTINUE TREATING THE PATIENT, BUT THE PATIENT WAS ULTIMATELY NOT SUCCESSFULLY TREATED AND DIED ON THE AFTERNOON OF (B)(6) 2024. THE CUSTOMER INFORMED ON 2024-08-27 THAT THE SECOND DEVICE (S/N (B)(6)) HAD NO MALFUNCTION. PREVIOUS SERVICE WORKS ON THE DEVICE COULD NOT BE TRACED BACK, SINCE THE CUSTOMER DOES NOT HAVE A GETINGE PREVENTATIVE MAINTENANCE CONTRACT. THE AFFECTED ROTAFLOW CONSOLE WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND THE REPORTED FAILURE "ROM ERROR" COULD BE CONFIRMED. THE MCP00705057#RFC CONTROL BOARD KIT (ARTICLE NUMBER 701034051) HAS BEEN REPLACED. THE AFFECTED MCP00705057#RFC CONTROL BOARD WAS INVESTIGATED BY THE GETINGE LIFE-CYCLE-ENGINEERING (LCE) WITH THE FOLLOWING OUTCOME: A DEFECTIVE MEMORY CHIP IC8 WAS IDENTIFIED AS ROOT CAUSE. THE PROBABLE CAUSE OF THE DEFECT WAS EITHER A RANDOM DEFECT OR ESD (ELECTROSTATIC DISCHARGE) DAMAGE. THE REPORTED FAILURE AND THE APPLICATION METHOD DESCRIBED BY THE CUSTOMER WAS EVALUATED BY GETINGE MEDICAL AFFAIRS TEAM ON 2024-09-18 WITH THE FOLLOWING OUTCOME: "THE COMPLAINT NARRATIVE DESCRIBES THE RESCUE ATTEMPT FOR A 58-YEAR-OLD PATIENT USING EXTRACORPOREAL SUPPORT. FROM THE COMPLAINT NARRATIVE AND PAST MEDICAL HISTORY OF ACUTE CORONARY SYNDROME AND SUDDEN CARDIAC ARREST, IT CAN BE PRESUMED TO HAVE BEEN A VENO-ARTERIAL CANNULATION FOR EXTRACORPOREAL CARDIOPULMONARY RESUSCITATION (ECPR). AFTER SUCCESSFUL CANNULATION AND AN UNSPECIFIED, PRESUMABLY SHORT AMOUNT OF TIME, THE ROTAFLOW DISPLAY NOT DISPLAY VALUES AND THE PUMP STOPPED. AS REPORTED BY THE CUSTOMER, NO AUDIBLE ALARM WAS PROVIDED. THE EMERGENCY DRIVE OF THE ROTAFLOW WAS EMPLOYED TO SUPPORT THE PATIENT FOR 2 HOURS, UNTIL A REPLACEMENT CONSOLE COULD BE BROUGHT IN FROM ANOTHER HOSPITAL. AFTER THE CONSOLE WAS REPLACED, NO FURTHER TECHNICAL PROBLEMS OCCURRED. THE PATIENT EXPIRED ON THE SAME DAY. THE ERROR OCCURRENCE WAS CONFIRMED BY A SERVICE TECHNICIAN. AFTER REPLACEMENT OF THE CONTROL BOARD THE CONSOLE WAS RETURNED TO THE CUSTOMER IN GOOD WORKING CONDITION. THE CONTROL BOARD WAS INVESTIGATED AND LCE CONFIRMED THE MALFUNCTION TO HAVE BEEN CAUSED BY THE MEMORY CHIP IC8. AS THE CONSOLE WAS LESS THAN FOUR YEARS OLD, WEAR-RELATED EFFECTS WERE EXCLUDED AS LIKELY ROOT CAUSES. THE REPORT CONCLUDES THAT ¿THE PROBABLE CAUSE OF THE DEFECT WAS EITHER A RANDOM DEFECT OR ESD DAMAGE.¿ AS THE DEVICE CAUSING USUALLY PROTECTS THE COMPONENTS FROM ESD EFFECTS, THAT LEAVES THE ¿RANDOM DEFECT¿ AS THE LAST LIKELY CANDIDATE. THE IRREGULARITY OBSERVED IN THE OPERATING HOUR METERS IS INDICATIVE THAT THE YEARLY SCHEDULED SERVICE WAS EITHER INCOMPLETE OR NOT PERFORMED, AS DESCRIBED IN THE LCE REPORT. NO PREVENTIVE ACTIONS COULD BE RECOMMENDED IN THE LCE REPORT. THE LOSS OF FUNCTION IN THE ROTAFLOW CONSOLE CAUSED A PUMP STOP, REQUIRING THE USE OF THE EMERGENCY DRIVE AND REPLACEMENT BY ANOTHER CONSOLE. THE IMPACT OF THE MALFUNCTION ON THE EVENTUAL EXPIRATION OF THE PATIENT, BY DELAYING OTHER INTERVENTIONS, COULD NOT BE DETERMINED. HOWEVER, THE INTERRUPTION OF BLOOD FLOW FROM THE NON-FUNCTIONAL ROTAFLOW MAY HAVE CONTRIBUTED TO FLOW DEPENDENT SEQUELAE, DEPENDING ON THE TRANSITION TIME OF SWITCHING FROM THE ROTAFLOW TO THE EMERGENCY DRIVE, AS WELL AS THE FLOW GENERATED BY THE USER OF THE EMERGENCY DRIVE, BOTH OF WHICH ARE UNDISCLOSED. LAST, IT IS UNKNOWN HOW THE EXISTING COMORBIDITIES (I.E., A HISTORY OF ACUTE CORONARY SYNDROME AND SUDDEN CARDIAC ARREST) INFLUENCED THE OUTCOME OF THE PATIENT." THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2024-07-17 AND DURING THE PERIOD OF (B)(6) 2020 TO (B)(6) 2024 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 (B)(6) 2020. FOR THE AFFECTED SERIAL NUMBER WITHIN THE TIMEFRAME OF THE SEARCH NO ADDITIONAL COMPLAINT WAS FOUND FOR THE SAME ISSUE. THE FOLLOWING IFU SECTION SHOULD BE FOLLOWED IN CASE OF AN "ESD (ELECTROSTATIC DISCHARGE) DAMAGE" HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / 15. 14 APPLIED STANDARDS THE ROTAFLOW SYSTEM IS INTENDED FOR OPERATION IN THE ELECTROMAGNETIC ENVIRONMENT DETAILED BELOW. THE CUSTOMER OR THE USER OF THE DEVICE SHOULD ENSURE THAT IT IS USED IN SUCH AN ENVIRONMENT. ELECTROSTATIC DISCHARGE (ESD) - FLOORS SHOULD BE WOOD, CONCRETE OR CERAMIC TILE. IF FLOORS ARE COVERED WITH SYNTHETIC MATERIAL, THE RELATIVE HUMIDITY SHOULD BE AT LEAST 30%. FUTHERMORE IT IS STATED IN THE SERVICE MANUAL HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM EN-03 · GLOBAL · 2020-07 1.6 PRECAUTIONARY MEASURES ELECTROSTATIC DISCHARGE CAN CAUSE DAMAGE TO ELECTRONIC COMPONENTS. TO PREVENT DAMAGE TO ESD-SENSITIVE COMPONENTS, AN ESD-PROTECTED ENVIRONMENT MUST BE SET UP. TO PREVENT DAMAGE AND MALFUNCTIONS, DEFINED HANDLING INSTRUCTIONS MUST BE OBSERVED WHEN HANDLING ESD SENSITIVE COMPONENTS. THE ESD-PROTECTION EQUIPMENT MUST ALWAYS BE USED APPROPRIATELY. 3.3 BATTERY REPLACEMENT, INTERNAL CHECK AND CLEANING OF RFC CLEAN THE FAN AND INSIDE THE UNIT WITH COMPRESSED DRY AIR (PREFERRED) OR AN ESD SAFE BRUSH. 6 REPAIR ESD SENSITIVE COMPONENTS! WHEN HANDLING ESD SENSITIVE DEVICES, ESTABLISHED PROCEDURES MUST BE OBSERVED TO PREVENT DAMAGE. WHEN WORKING WITH ESD SENSITIVE COMPONENTS, ALWAYS USE A GROUNDED WRISTBAND AND A GROUNDED WORK SURFACE. ADEQUATE SERVICE TOOLS MUST ALWAYS BE USED. THE FOLLOWING IFU SECTION SHOULD BE FOLLOWED IN REGARDS TO THE REGULAR SEVICE OF THE DEVICE "HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / 15. 10 MAINTENANCE EVERY 12 MONTHS A INSPECTION MUST BE CARRIED OUT BY AN AUTHORIZED SERVICE. 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.
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.
COMPLAINT ID: (B)(4).
THE EVENT OCCURRED IN CHINA. IT WAS INITIALLY REPORTED THAT THE DISPLAY ON THE ROTAFLOW CONSOLE WENT BLACK DURING PATIENT USE. THE EMERGENCY HAND CRANK WAS USED. ON 2024-07-19 THE SSU PROVIDED THAT THE PUMP HAS STOPPED, AND THE DEVICE WAS REPLACED WITH ANOTHER DEVICE (LOANER UNIT FROM ANOTHER HOSPITAL). FURTHERMORE, IT WAS REPORTED THAT THE MESSAGE ¿ROM ERROR¿ OCCURRED, THE CONTROL BOARD WAS DETECTED AS DEFECTIVE. A GETINGE FIELD SERVICE TECHNICIAN REPLACED THE AFFECTED CONTROL BOARD, AND THE DEVICE IS WORKING AS INTENDED. FURTHER IT WAS REPORTED THAT THE PATIENT EXPIRED. DUE TO THE DEATH OF THE PATIENT A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2479358 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | MCP00706291#ROTAFLOW PUMP MODULE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male | Death |