HEART LUNG MACHINE
Report
- Report Number
- 3013876692-2025-00069
- Event Type
- Death
- Date Received
- August 15, 2025
- Date of Event
- July 27, 2025
- Report Date
- October 23, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- UDI-DI
- 04037691718910
- PMA / PMN Number
- K991864
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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: THIS EVENT OCCURRED ON THE CHINESE MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, ROTAFLOW CONSOLE¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K991864. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR ROTAFLOW CONSOLE WITH CATALOG NUMBER 701046405.
THE EVENT OCCURRED IN CHINA. ON (B)(6) 2025, THE PATIENT WAS A 9-MONTH-OLD MALE INFANT WEIGHING 8.9KG. PATIENT WAS CONNECTED TO THE ECMO MACHINE. DURING THE TRANSFER FROM THE OPERATING ROOM TO THE CICU, THE CENTRIFUGAL PUMP TRIGGERED AN ALARM OF LOW BAT. IMMEDIATELY, THE EMERGENCY HAND CRANK WAS USED TO PUMP BLOOD AND THE TRANSFER CONTINUED. IMMEDIATELY AFTER THE CHILD WAS TRANSFERRED TO THE CICU, A NEW PUMP WAS REPLACED FOR THE CHILD, AND THE PUMP REPLACEMENT TOOK APPROXIMATELY 30 SECONDS. SUBSEQUENTLY, THE REPLACED PUMP WAS CONTINUED TO BE USED TO TREAT THE CHILD PATIENT, WHICH WAS FUNCTIONING AS INTENDED. THE CHILD PATIENT WAS SUCCESSFULLY REMOVED FROM ECMO ON (B)(6) 2025. 48 HOURS AFTER THE WEANING, THE CHILD PATIENT DEVELOPED SEVERE COMPLICATIONS OF CENTRAL NERVOUS SYSTEM SEPTIC SHOCK. THE FAMILY GAVE UP TREATMENT AND THE PATIENT PASSED AWAY. CUSTOMER CONFIRMED THAT THERE WAS NO RELATION BETWEEN THIS INCIDENT AND THE PATIENT OUTCOME (EXPIRATION). DUE TO THE REPORTED DEATH OF THE PATIENT A REPORT IS REQUIRED. TAKING INTO ACCOUNT ALL INFORMATION PROVIDED, INCLUDING THE CUSTOMER¿S FORMAL ASSESSMENT, IT IS CONCLUDED THAT THE PATIENT¿S EXPIRATION IS NOT CAUSALLY RELATED TO THE INCIDENT DESCRIBED. IN REGARDS TO THE REPORTED FAILURE LOW BAT ALARM: ACCORDING TO THE GETINGE SSU (SALES AND SERVICE UNIT) DATED ON 2025-10-03 THE BATTERY HAS NOT BEEN REPLACED SINCE 2022. THEREFORE, THE ROOT CAUSE FOR THE BATTERY FAILURE COULD BE DETERMINED AS THE LIFETIME OF THE BATTERY WAS PASSED AND REPLACEMENT OVERDUE AND THE BATTERY REACHED ITS USEFUL LIFETIME. CONFIRMED BY CUSTOMER TOO, THAT THE BATTERY WILL BE REPLACED BY THE THIRD-PARTY BATTERY. NO SERVICE ORDER CAN BE PROVIDED AS NO SERVICE WAS ORDERED BY THE CUSTOMER WITH GETINGE ON THAT DEVICE. THE AFFECTED BATTERY HAS BEEN REQUESTED FOR RETURN HOWEVER, THE BATTERY IS NOT MADE AVAILABLE BY THE CUSTOMER. IN ORDER TO INVESTIGATE THE LOW BAT ALARM AND UNMAINTAINED BATTERY, AN INTERNAL NONCONFORMITY WAS INITIATED. ALL FURTHER INVESTIGATIONS WILL BE CONDUCTED IN THE NC. A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON (B)(6) 2025 WITH FOLLOWING CONCLUSION: "BASED ON THE INFORMATION PROVIDED IN THE COMPLAINT AND THE ACCOMPANYING QUESTIONNAIRE, THE REPORTED INCIDENT INVOLVED A LOW BATTERY ALARM DURING PATIENT TRANSPORT ON (B)(6) 2025, WHILE USING A ROTAFLOW ECMO SYSTEM ON A 9-MONTH-OLD INFANT. THE ECMO SYSTEM HAD BEEN CONTINUOUSLY CHARGED FOR AT LEAST FOUR HOURS PRIOR TO TRANSPORT, AND THE ¿BATTERY CHARGING¿ INDICATOR LIGHT WAS ILLUMINATED. APPROXIMATELY 30 SECONDS AFTER THE SYSTEM WAS UNPLUGGED, THE LOW BATTERY ALARM OCCURRED. MANUAL PUMPING WAS IMMEDIATELY INITIATED, AND THE PATIENT WAS SUBSEQUENTLY CONNECTED TO A REPLACEMENT PUMP IN THE CICU. NO TECHNICAL MALFUNCTION OF THE DEVICE WAS REPORTED, AND ECMO THERAPY CONTINUED WITHOUT FURTHER ISSUES. THE PATIENT WAS SUCCESSFULLY WEANED FROM ECMO ON (B)(6) 2025, BUT LATER DEVELOPED CENTRAL NERVOUS SYSTEM SEPTIC SHOCK AND DIED AFTER TREATMENT WAS DISCONTINUED BY THE FAMILY. ACCORDING TO THE HOSPITAL¿S RESPONSES, THE BATTERY HAD NEVER BEEN INSPECTED OR REPLACED SINCE 2022, AND THE HOSPITAL HAD NOT ADHERED TO THE RECOMMENDED SERVICE SCHEDULE. THE IFU ROTAFLOW, CHAPTER 10 ¿MAINTENANCE,¿ SPECIFIES THAT REGULAR MAINTENANCE AND INSPECTION MUST BE PERFORMED TO ENSURE SAFE AND RELIABLE DEVICE OPERATION. MAINTENANCE REQUIREMENTS INCLUDE CHECKING THE BATTERY CAPACITY EVERY SIX MONTHS, PERFORMING A FULL INSPECTION EVERY TWELVE MONTHS BY AUTHORIZED SERVICE PERSONNEL, AND REPLACING THE BATTERIES EVERY TWENTY-FOUR MONTHS. FURTHERMORE, THE IFU STATES THAT BATTERIES MUST BE REPLACED IF THEY CANNOT BE FULLY CHARGED WITHIN 8.5 HOURS OR IF FULLY CHARGED BATTERIES FAIL TO MEET THE DEFINED OPERATING SPECIFICATIONS. MAINTENANCE WORK, INSPECTION, AND BATTERY REPLACEMENT ARE TO BE CONDUCTED EXCLUSIVELY BY AUTHORIZED SERVICE PERSONNEL TO MAINTAIN DEVICE SAFETY AND PERFORMANCE INTEGRITY. IN THIS CASE, THE BATTERY HAD NOT BEEN REPLACED WITHIN THE REQUIRED 24-MONTH INTERVAL AND HAD NOT UNDERGONE THE PRESCRIBED 6-MONTH CAPACITY CHECKS OR ANNUAL INSPECTIONS BY AUTHORIZED SERVICE PERSONNEL (PLEASE REFER TO QUESTION AND ANSWER 4 OF THE QUESTIONNAIRE IN CHAPTER 1.6.5 AND THE COMMUNICATION SECTION OF THE CUSTOMER PRODUCT COMPLAINT SINGLE REPORT). THE HOSPITAL ALSO INDICATED THAT IT CONSIDERED ORIGINAL BATTERIES TOO COSTLY AND WAS EXPLORING THIRD-PARTY ALTERNATIVES. AS A RESULT, THE DEVICE WAS OPERATED WITH A BATTERY THAT WAS BEYOND THE RECOMMENDED SERVICE LIFE AND HAD NOT BEEN VERIFIED FOR CONTINUED PERFORMANCE CAPABILITY. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE INCIDENT IS THE USE OF AN OVERDUE AND UNMAINTAINED BATTERY, WHICH FAILED TO PROVIDE ADEQUATE CHARGE DURING TRANSPORT. THIS CONDITION IS CONSISTENT WITH NON-ADHERENCE TO THE PREVENTIVE MAINTENANCE AND REPLACEMENT REQUIREMENTS SPECIFIED IN THE ROTAFLOW INSTRUCTIONS FOR USE. FURTHERMORE, ACCORDING TO THE CUSTOMER¿S STATEMENT IN QUESTION AND ANSWER 11 OF THE QUESTIONNAIRE (PLEASE REFER TO CHAPTER 1.6.5) THE PATIENT¿S EXPIRATION HAS BEEN ASSESSED AS UNRELATED TO THE REPORTED INCIDENT. TAKING INTO ACCOUNT ALL INFORMATION PROVIDED, INCLUDING THE CUSTOMER¿S FORMAL ASSESSMENT, IT IS CONCLUDED THAT THE PATIENT¿S EXPIRATION IS NOT CAUSALLY RELATED TO THE INCIDENT DESCRIBED. THE IDENTIFIED ROOT CAUSE REMAINS THE UTILIZATION OF AN OVERDUE AND UNMAINTAINED BATTERY, REPRESENTING A DEVIATION FROM THE MANUFACTURER¿S PRESCRIBED MAINTENANCE AND REPLACEMENT SCHEDULE." BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED BUT IS NOT RELATED TO THE PATIENT`S DEATH. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON (B)(6) 2025 AND DURING THE PERIOD OF 2022-07-12 TO 2025-08-11 IT SHOWS A NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THE AFFECTED ROTAFLOW CONSOLE WAS PRODUCED IN 2022-07-12. 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 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 3.3.4 CHECK BATTERY CAPACITY EVERY 6 MONTHS, AT THE LATEST. THE BATTERY MUST BE REPLACED BY THE AUTHORIZED TECHNICAL SERVICE EVERY 2 YEARS, AT THE LATEST. THE BATTERY MUST BE REPLACED SOONER IF IT CANNOT BE FULLY CHARGED WITHIN 8.5 HOURS OR IF THE SYSTEM CANNOT BE OPERATED WITH THE FULLY CHARGED BATTERY. THE ACTUAL RUN TIME DURING BATTERY OPERATION DEPENDS ON THE AGE AND CONDITION OF THE BATTERIES, CURRENT CONSUMPTION OF THE ROTAFLOW CONSOLE AND OTHER FACTORS. THE RUN TIME SHOWN IS ONLY A REFERENCE VALUE. THE ACTUAL RUN TIME CAN BE SHORTER OR LONGER. CHAPTER 5.6.1 BEFORE STARTING THE APPLICATION, CHECK THE POINTS LISTED IN "CHECK BEFORE EVERY USE". BEFORE EACH USE, ENSURE THAT THE BATTERIES ARE FULLY CHARGED. IF THE BATTERY CAPACITY IS LOW AN ACOUSTIC SIGNAL SOUNDS ON THE DEVICE. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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 EVENT OCCURRED IN CHINA. ON (B)(6) 2025, THE PATIENT WAS A 9-MONTH-OLD MALE INFANT WEIGHING 8.9KG. PATIENT WAS CONNECTED TO THE ECMO MACHINE. DURING THE TRANSFER FROM THE OPERATING ROOM TO THE CICU, THE CENTRIFUGAL PUMP TRIGGERED AN ALARM OF LOW BAT. IMMEDIATELY, THE EMERGENCY HAND CRANK WAS USED TO PUMP BLOOD AND THE TRANSFER CONTINUED. IMMEDIATELY AFTER THE CHILD WAS TRANSFERRED TO THE CICU, A NEW PUMP WAS REPLACED FOR THE CHILD, AND THE PUMP REPLACEMENT TOOK APPROXIMATELY 30 SECONDS. SUBSEQUENTLY, THE REPLACED PUMP WAS CONTINUED TO BE USED TO TREAT THE CHILD PATIENT. THE EQUIPMENT DID NOT MALFUNCTION. THE CHILD PATIENT WAS SUCCESSFULLY REMOVED FROM ECMO ON (B)(6) 2025. 48 HOURS AFTER THE WEANING, THE CHILD PATIENT DEVELOPED SEVERE COMPLICATIONS OF CENTRAL NERVOUS SYSTEM SEPTIC SHOCK. THE FAMILY GAVE UP TREATMENT AND THE PATIENT DIED. THE CUSTOMER STATES THAT THE INVOLVED BATTERY NEVER BEEN INSPECTED OR REPLACED. FURTHER THERE WAS NO RELATION BETWEEN THIS INCIDENT AND THE PATIENT OUTCOME (EXPIRATION). DUE TO THE REPORTED DEATH OF THE PATIENT A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1300984 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | MCP00706291#ROTAFLOW CHINESE ZH-PLUG | 04037691718910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 MO | Male | Death |