HEART LUNG MACHINE
Report
- Report Number
- 3013876692-2025-00020
- Event Type
- Death
- Date Received
- March 21, 2025
- Date of Event
- January 29, 2025
- Report Date
- January 7, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE EVENT OCCURRED IN INDIA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿LAMPTEST¿ WAS DISPLAYED ON THE ROTAFLOW CONSOLE. IT WAS NOTICED DURING PATIENT TREATMENT AND THE DEVICE WAS IMMEDIATELY EXCHANGED WITH A BACKUP DEVICE. DURING SERVICE THE ERROR MESSAGE ¿HEAD ERROR¿ WAS DISPLAYED ON THE ROTAFLOW CONSOLE. NEW INFORMATION HAS BEEN PROVIDED BY THE SSU (SALES AND SERVICE UNIT) DATED ON (B)(6) 2025 THAT THE PATIENT PASSED AWAY (B)(6) 2025. DUE TO THE REPORTED DEATH OF THE PATIENT A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN INVESTIGATED THE AFFECTED ROTAFLOW CONSOLE (RFC) WITH SERIAL NUMBER (B)(6) AND THE ROTAFLOW DRIVE (RFD) WITH SERIAL NUMBER (B)(6) ON (B)(6) 2025. NO MALFUNCTION ON THE RFC COULD BE DETECTED AT THIS TIME. THE RFD WAS DETECTED AS DEFECTIVE AND NEEDS TO THE REPAIRED. HOWEVER, ON (B)(6) 2025 THE SSU (SALES AND SERVICE UNIT) REPORTED THAT THE CONTROL BOARD ON THE ROTAFLOW CONSOLE WAS ALSO DETECTED AS DEFECTIVE. ACCORDING TO THE SERVICE ORDER DATED ON (B)(6) 2025 THE RFC CONTROL BOARD KIT (ARTICLE NUMBER 70103.4051) HAS BEEN REPLACED ON THE ROTAFLOW CONSOLE. AFTER THE REPLACEMENT THE RFC IS WORKING AS INTENDED. THE ROTAFLOW DRIVE (RFD) HAS BEEN REQUESTED FOR RETURN UNDER RMA 60680 ON (B)(6) 2025 HOWEVER, IT IS NOT POSSIBLE TO RETURN THE RFD BACK FOR FURTHER INVESTIGATION DUE TO REIMPORT REASON OF MEDICAL DEVICES FROM INDIA. THE AFFECTED RFD IS OUT OF USE. THE AFFECTED CONTROL BOARD HAS BEEN REQUESTED FOR RETURN ON (B)(6) 2025 HOWEVER THE SSU (SALES AND SERVICE UNIT) CONFIRMED ON (B)(6) 2025 THAT THE CONTROL BOARD HAS BEEN SCRAPPED AND IS NO LONGER AVAILABLE FOR FURTHER INVESTIGATION. AS THE AFFECTED ROTAFLOW DRIVE AND CONTROL BOARD ARE NOT AVAILABLE FOR FURTHER INVESTIGATION THE EXACT ROOT CAUSES COULD NOT BE DETERMINED. HOWEVER, A SIMILAR COMPLAINT WAS INVESTIGATED FOR THE REPORTED FAILURE "LAMPTEST ERROR" IN GETINGE LIFE-CYCLE-ENGINEERING (LCE) AND THE MOST POSSIBLE ROOT CAUSE COULD BE DETERMINED AS AN INTERNAL DEFECT OF THE INTEGRATED CIRCUIT OF THE DISPLAY IC3. THE BIT "D0" IS PERMANENTLY PULLED HIGH. PRESUMABLY IT IS A STATISTICAL FAILURE. THE HEAD ERROR IS MOSTLY 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. A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON (B)(6) 2025 WITH FOLLOWING CONCLUSION: "BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE FOR THE REPORTED DEVICE BEHAVIOR CANNOT BE ESTABLISHED. THE DOCUMENTATION CONTAINS INCONSISTENT TECHNICAL CONCLUSIONS ACROSS SERVICE REPORTS. FURTHER, PATIENT DATA OR DETAILED INCIDENT CIRCUMSTANCES WERE PROVIDED. AS A RESULT, A COMPREHENSIVE ROOT CAUSE ANALYSIS CANNOT BE PERFORMED. ONLY REASONABLE ASSUMPTIONS CAN BE DISCUSSED/PROPOSED. THE OBSERVED BEHAVIORS INCLUDE REPORTED ¿ERROR LAMP TEST,¿ ¿HEAD ERROR,¿ AND ¿HEAD ALARM¿ MESSAGES, AS WELL AS STATEMENTS THAT THE DEVICE STOPPED INTERMITTENTLY DURING PATIENT USE. ACCORDING TO THE INSTRUCTIONS FOR USE, A VISUAL ERROR MESSAGE ¿ERROR!! HEAD¿ WITH ACOUSTIC ALARM AND PUMP STOP MAY OCCUR IF THE DRIVE IS REMOVED OR CONNECTED WHILE THE CONSOLE IS SWITCHED ON, IF THE DEVICE IS DAMAGED, OR IF MAGNETIC UNCOUPLING OF THE CENTRIFUGAL PUMP OCCURS DURING REMOVAL, INSERTION, OR SHAKING AT 0 RPM. THE IFU ALSO DESCRIBES A ¿LAMPTEST¿ STATUS DISPLAY AS A DISPLAY-RELATED ERROR CONDITION. IN THE ABSENCE OF CONFIRMED TECHNICAL FINDINGS, REASONABLE AND POSSIBLE ROOT CAUSES THEREFORE INCLUDE INTERMITTENT MAGNETIC UNCOUPLING OF THE CENTRIFUGAL PUMP, IMPROPER HANDLING OF THE DRIVE OR PUMP DURING OPERATION, ELECTRICAL OR ELECTRONIC FAULTS WITHIN THE DRIVE OR CONTROL ELECTRONICS, OR A DISPLAY-RELATED MALFUNCTION. THE DIFFERENCE BETWEEN THE (B)(6) 2025 SERVICE REPORT, WHICH SUSPECTED AN RF DRIVE ISSUE, AND THE (B)(6) 2025 SERVICE REPORT, WHICH REPLACED THE RFC CONTROL BOARD, MAY SUGGEST DIFFERING ORIGINS REGARDING THE TECHNICAL ROOT CAUSE. WITH RESPECT TO DEVICE PERFORMANCE, THE AVAILABLE INFORMATION SUGGESTS A POTENTIAL MALFUNCTION OR MALPERFORMANCE, AS THE UNIT WAS REPORTED TO STOP DURING USE AND TO GENERATE ERROR MESSAGES CONSISTENT WITH PUMP STOP CONDITIONS DESCRIBED IN THE IFU. HOWEVER, DUE TO THE LACK OF OBJECTIVE DATA, SUCH AS A CONFIRMED FAILURE ANALYSIS, PATIENT DATA, OR DETAILED DESCRIPTION ON THE GENERAL INCIDENT CIRCUMSTANCES, IT CANNOT BE CONCLUSIVELY DETERMINED WHETHER A DEVICE MALFUNCTION OCCURRED, WHETHER ANY DECREASE IN PERFORMANCE DIRECTLY ALIGNED WITH THE EVENT DESCRIBED IN THE COMPLAINT, OR WHETHER A USE ERROR (E.G., ¿HOT SWAPPING¿ THE DRIVE (RFD) WHILE THE CONSOLE IS POWERED ON) CONTRIBUTED TO (OR CAUSED) THE REPORTED ERROR. THE EXPIRATION OF THE PATIENT WAS REPORTED IN INFORMATION RECEIVED ON (B)(6) 2025. BASED ON THE AVAILABLE DOCUMENTATION, THERE IS INSUFFICIENT INFORMATION TO ESTABLISH A CAUSAL RELATIONSHIP, OR TO EXCLUDE A RELATIONSHIP, BETWEEN THE USE OF THE ROTAFLOW DEVICE AND THE PATIENT OUTCOME. NO DETAILS WERE PROVIDED REGARDING THE PATIENT¿S CLINICAL CONDITION, INDICATION FOR USE OF THE DEVICE, COMORBIDITIES, DURATION OF THERAPY, TIMING OF THE DEVICE BEHAVIOR RELATIVE TO THE PATIENT OUTCOME, OR ANY CLINICAL INTERVENTIONS PERFORMED. WITHOUT THIS INFORMATION, AN ASSOCIATION OR LACK OF ASSOCIATION BETWEEN THE REPORTED DEVICE BEHAVIOR AND THE EXPIRATION OF THE PATIENT CANNOT BE DETERMINED. THAT SAID, A DELAY IN SUPPORT MAY HAVE CONTRIBUTED TO EXISTING COMORBIDITIES IN AN AT-RISK PATIENT POPULATION REQUIRING EXTRACORPOREAL SUPPORT (E.G., HEMODYNAMICALLY DECOMPENSATING). THERE IS ALSO NO INFORMATION AVAILABLE TO CONFIRM WHETHER A USE ERROR OCCURRED. WHILE THE IFU LISTS SCENARIOS IN WHICH ERRORS MAY ARISE DUE TO HANDLING OF THE DRIVE OR PUMP WHILE THE CONSOLE IS POWERED ON, NO EVIDENCE WAS PROVIDED REGARDING USER ACTIONS AT THE TIME OF THE INCIDENT. THEREFORE, IT CANNOT BE ASSESSED WHETHER A USE ERROR OCCURRED OR WHETHER SUCH AN ERROR MAY HAVE CONTRIBUTED TO PATIENT OUTCOME. THE COMORBIDITIES OF THE PATIENT REMAIN UNKNOWN. NO INFORMATION REGARDING THE PATIENT¿S UNDERLYING DISEASE, SEVERITY OF ILLNESS, OR COMORBID CONDITIONS WERE PROVIDED. FURTHER, NO RESPONSE TO THE SENT QUESTIONNAIRE WAS RECEIVED. CONSEQUENTLY, IT IS NOT POSSIBLE TO ASSESS WHETHER PATIENT-RELATED FACTORS LIKELY CONTRIBUTED TO THE OUTCOME OF THE PATIENT. POTENTIAL HAZARDOUS SITUATIONS THAT CAN BE REASONABLY ASSUMED, BASED ON THE IFU AND SERVICE DOCUMENTATION, INCLUDE INTERRUPTION OF PUMP FUNCTION DUE TO HEAD ERROR OR MAGNETIC UNCOUPLING, UNEXPECTED PUMP STOP DURING TREATMENT, OR FAILURE OF THE DEVICE TO OPERATE AS INTENDED. HOWEVER, WHETHER ANY OF THESE SITUATIONS OCCURRED AT THE TIME OF THE PATIENT DECEASE CANNOT BE CONFIRMED. IN SUMMARY, WHILE THE EXPIRATION OF THE PATIENT WAS REPORTED, THERE IS INSUFFICIENT AND INCONSISTENT INFORMATION 1) TO DETERMINE EITHER A DEFINITIVE OR PROPOSED ROOT CAUSE OF THE DEVICE BEHAVIOR, 2) TO CONFIRM A DEVICE MALFUNCTION WITH CERTAINTY, OR 3) TO ESTABLISH A POSSIBLE CAUSAL ASSOCIATION BETWEEN THE DEVICE AND THE PATIENT OUTCOME. DUE TO THE LACK OF DETAILED INCIDENT DATA, PATIENT INFORMATION, AND THE DISCREPANCIES BETWEEN THE COMPLAINT STATEMENT AND SERVICE DIAGNOSES, A CONCLUSIVE ROOT CAUSE ANALYSIS IS NOT POSSIBLE. ONLY THOSE ASSUMPTIONS BASED ON IFU-DESCRIBED ERROR CONDITIONS AND LIMITED-SERVICE FINDINGS CAN BE PROPOSED." BASED ON THE PROVIDED PHOTOGRAPHICAL EVIDENCE BY THE CUSTOMER THE REPORTED "LAMPTEST" COULD BE CONFIRMED AND THE "HEAD ERROR" WHICH OCCURRED DURING SERVICE COULD ALSO BE CONFIRMED. FOR THE ROTAFLOW CONSOLE SERIAL NUMBER (B)(6) AND THE ROTAFLOW DRIVE S/N (B)(6): A REVIEW OF NON-CONFORMITIES WAS PERFORMED ON (B)(6) 2025 AND DURING THE TIME FROM (B)(6) 2021 TO (B)(6) 2025 THERE ARE NO NON-CONFORMITIES IN REGARD TO THE REPORTED PRODUCTS AND FAILURES. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE ROTAFLOW CONSOLE IN QUESTION WAS PRODUCED ON (B)(6) 2021 AND THE ROTAFLOW DRIVE WAS PRODUCED IN (B)(6) 2021. 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 "HEAD ERROR", 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. CHAPTER 2.2.3. TAKE DAMAGED DEVICES OUT OF SERVICE IMMEDIATELY AND HAVE THEM TESTED BY THE AUTHORIZED SERVICE PERSONNEL. THE CUSTOMER WILL ALSO BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE SERVICE MANUAL FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ EN / 03 CHAPTER 1.7 SERVICE-RELATED WORK ON A DEVICE MAY ONLY BE CARRIED OUT BY SERVICE TECHNICIANS WHO HAVE BEEN TRAINED AND INSTRUCTED AND CERTIFIED BY GETINGE. SERVICE-RELATED WORK ON A DEVICE CARRIED OUT BY UNQUALIFIED SERVICE TECHNICIANS MAY LEAD TO INJURY OF THE SERVICE TECHNICIAN, PATIENT OR OTHER PERSONS OR MAY LEAD TO DEVICE DAMAGE. CHAPTER 1.10 A REPAIR IS CARRIED OUT FOR MAINTENANCE AFTER DAMAGE OR MALFUNCTION OF A ROTAFLOW SYSTEM. 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.
ON 2025-09- 27 GETINGE SSU (SALES AND SERVICE UNIT) REPORTED THAT A CROSS CHECK WAS PERFORMED AND THE CONTROL BOARD ON THE ROTAFLOW CONSOLE WAS ALSO DETECTED AS DEFECTIVE. THE ROTAFLOW DRIVE HAS BEEN REQUESTED FOR RETURN ON 2025-02-04 AND THE CONTROL BOARD HAS BEEN REQUESTED FOR RETURN ON 2025-09-29 BUT BOTH NOT RECEIVED YET. FOR THE ROTAFLOW CONSOLE SERIAL NUMBER (B)(6) AND THE ROTAFLOW DRIVE S/N (B)(6): A REVIEW OF NON-CONFORMITIES WAS PERFORMED ON (B)(6) 2025 AND DURING THE TIME FROM 2021-05-17 TO 2025-01-29 THERE ARE NO NON-CONFORMITIES IN REGARDS 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 IN QUESTION WAS PRODUCED ON 2021-05-17 AND THE ROTAFLOW DRIVE WAS PRODUCED IN 2021-05-18. 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. THE INVESTIGATION IS ONGOING. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
ORIGINALLY IT WAS REPORTED TO THE FACTORY- THE EVENT OCCURRED IN INDIA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿LAMPTEST¿ WAS DISPLAYED ON THE ROTAFLOW CONSOLE. IT WAS NOTICED DURING PATIENT TREATMENT AND THE DEVICE WAS IMMEDIATELY EXCHANGED WITH A BACKUP DEVICE. DURING SERVICE THE ERROR MESSAGE ¿HEAD ERROR¿ OCCURRED ON THE ROTAFLOW CONSOLE. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE REPORTED EXCHANGE OF THE DEVICE DURING PATIENT TREATMENT AND DUE TO THAT THE REPORTED FAILURE "HEAD ERROR" COULD LEAD TO THE PUMP STOP A REPORT IS REQUIRED. COMPLAINT ID: (B)(4). NEW INFORMATION WAS THEN PROVIDED BY THE SSU DATED ON (B)(6) 2025 THAT THE PATIENT PASSED AWAY. COMPLAINT ID: (B)(4). THIS FACILITATED AN INITIAL MDR TO BE FILED BY THE SSU.
COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 337088 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | MCP00706041#ROTAFLOW ENGLISH/UK UK-PLUG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Female | Death | UNKNOWN. |