CARDIOHELP
Report
- Report Number
- 3013876692-2025-00043
- Event Type
- Death
- Date Received
- June 4, 2025
- Date of Event
- May 27, 2025
- Report Date
- July 11, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- UDI-DI
- 04037691658384
- PMA / PMN Number
- K133598
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION ON 2025-05-27. NO PART WAS REPLACED. THE FAILURE OCCURRED DUE TO AN USER ERROR. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE LOG FILES OF THE REPORTED CARDIOHELP DEVICE WERE REVIEWED AND THE DEVICE DEFECTIVE COULD BE CONFIRMED ON THE DATE OF EVENT. FURTHER THE GETINGE FST CONFIRMED THAT THE USER ERROR WAS VISIBLE IN THE LOGFILES. THE GETINGE FST CONFIRMED THAT THE HOSPITAL STAFF WILL RECEIVE AN TRAINING ON HOW TO HANDLE THE CARDIOHELP IN THIS KIND OF SITUATIONS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE DENMARK MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, CARDIOHELP¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K133598. 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 CARDIOHELP WITH CATALOG NUMBER 701048012.
IT WAS REPORTED THAT THE PATIENT ARRIVED IN THE HOSPITAL WITH A LUCAS PUMP PUMPING FOR ONE HOUR AND THE PATIENT HAS A CLOSED LEFT ANTERIOR DESCENDING (LAD). IT WAS HARD TO CANNULATE THE PATIENT AS THE PATIENT WAS BLEEDING ACCORDING TO THE CUSTOMER FROM ¿EVERYWHERE¿. THIS WAS CAUSED DUE TO THE LONG-TERM USE OF THE LUCAS PUMP. THE PATIENT WAS PUT ON ECMO. A CORONARY ARTERIOGRAPHY (KAG) WAS DONE AND THE LAD WAS OPENED. THE CUSTOMER WANTED TO DO A SMALL BYPASS WITH THE CANNULATION TO SECURE THE BLOOD FLOW TO THE LEG AND THEN THE STAFF CLAMPED THE HLS SET. A DEVICE DEFECTIVE ERROR MESSAGE OCCURRED, AS THE CUSTOMER HAS REMOVED THE SET WHILE THE PUMP WAS RUNNING. THE PATIENT WAS HAND CRANKED AND THE CARDIOHELP DEVICE WAS REPLACED. NEW INFORMATION WAS RECEIVED ON 2025-06-02 THAT THE PATIENT REMAINED FOR 3,5 HOURS ON THE REPLACED CARDIOHELP DEVICE BEFORE THE PATIENT PASSED AWAY. THE GETINGE SERVICE TECHNICIAN CONFIRMED THAT THERE WAS NO FAULT ON THE SECOND HARDWARE DEVICE NOR ON THE DISPOSABLE USED. THE PATIENT PASSED HAD MASSIVE BLEEDING, WHICH WAS BEFORE AND AFTER COMING ON ECMO. FURTHER IT WAS DIFFICULT TO CANNULATE THE PATIENT. THE PATIENT PASSED AWAY DUE TO BLEEDING AND LOW BLOOD PRESSURE. PATIENT DEATH WAS REPORTED. AS THE CARDIOHELP DEVICE WAS REPLACED DURING TREATMENT, A REPORT IS REQUIRED. NEW INFORMATION RECEIVED ON 2025-06-04 THAT THE PATIENT DID NOT DIE DUE TO RELATED WRONG USER HANDLING ON THE DEVICE, BUT BECAUSE THE PATIENT WAS VERY SICK WHEN HE ARRIVED IN THE HOSPITAL. FURTHER THE LUCAS DEVICE WAS ON THE PATIENT FOR TWO HOURS AND LEAD TO A LOT IF INTERNAL BLEEDING. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION ON 2025-05-27. NO PART WAS REPLACED. THE FAILURE OCCURRED DUE TO AN USER ERROR. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE LOG FILES OF THE REPORTED CARDIOHELP DEVICE WERE REVIEWED AND THE DEVICE DEFECTIVE COULD BE CONFIRMED ON THE DATE OF EVENT. FURTHER THE GETINGE FST CONFIRMED THAT THE USER ERROR COULD BE ADDITIONALLY CONFIRMED IN THE LOGFILES. THE ROOT CAUSE OF THE DEVICE DEFECTIVE ERROR IS AN USER RELATED FAULT CONFIRMED BY THE GETINGE SERVICE AND SALES UNIT (REFER TO COMMUNICATION GRID). THE DISPOSABLE WAS DETACHED WITHOUT REDUCING THE RPM. THE GETINGE FST CONFIRMED THAT THE HOSPITAL STAFF WILL RECEIVE AN TRAINING ON HOW TO HANDLE THE CARDIOHELP IN THIS KIND OF SITUATIONS. (REFER TO SERVICE ORDER). A MEDICAL REVIEW WAS PERFORMED ON 2025-07-02 WITH FOLLOWING CONCLUSION: "AFTER REVIEWING ALL AVAILABLE STATEMENTS AND CLINICAL INFORMATION, THE FOLLOWING CRITICAL SITUATION WAS DESCRIBED BY THE CUSTOMER: AFTER IMPLANTATION OF A VA-ECMO, DUE TO A PROLONGED CARDIAC ARREST WITH A 49-YEAR-OLD PATIENT, THE CLINICAL TEAM DECIDED TO CONNECT AN ANTEGRADE CANNULA TO PROVIDE SUFFICIENT PERFUSION OF THE LEG. THE CUSTOMER STATES, THAT THE CARDIOHELP-I AND THE USED HLS-SET WERE PRIMED CORRECTLY AND WORKED AS INTENDED, AFTER SUBSTITUTION OF VOLUME, DUE TO HYPOVOLEMIA. FOR THE INTEGRATION OF THIS CANNULA TO THE ESTABLISHED CIRCUIT, THE SYSTEM WAS CLAMPED, MAINTAINING THE CARDIOHELP-I TO APPROX. 3000RPM, AND THE NEW CANNULA ATTACHED TO THE ARTERIAL LINE. AFTER OPENING THE CLAMPS, THE CIRCULATION DID NOT RESTART. SO, THE CUSTOMER IMMEDIATELY CHANGED TO THE EMERGENCY DRIVE AND AFTERWARDS USED A SECOND CARDIOHELP-I TO REESTABLISH CONTINUOUS PERFUSION OF THE PATIENT. AFTER REVIEWING THE SERVICE POOL DATA AND THE SERVICE-REPORT IT IS CONFIRMED THAT A BACKFLOW OCCURRED, AS A ¿BACKFLOW PREVENTION¿-ALARM WAS DETECTED ON THE (B)(6) 2025 AT 18:07. THE LOG-DATA FOLLOWING THIS ALARM SUGGEST THAT THE HLS-SET WAS REMOVED FROM THE CARDIOHELP-I AND NO RESET OF THE INITIAL ALARM WAS PERFORMED. COMPARING THE INFORMATION OF THE SERVICE POOL WITH THE AVAILABLE DATA FROM THE USER POOL, IT CAN BE SEEN, THAT THE CUSTOMER UNLOCKED THE DEVICE MANUALLY AT 18:07, THE GLOBAL OVERDRIVE WAS ACTIVATED AT 18:10. THE BACK FLOW PREVENTION AND ZERO FLOW WERE SWITCHED OFF AT THE SAME TIME. THE REASON FOR THIS BACKFLOW ALARM REMAINS UNCLEAR. WHEN LOOKING AT POSSIBLE CAUSES FOR THE DETECTED BACKFLOW, TECHNICAL ISSUES CAN BE RULED OUT, AS THE SERVICE REPORT DOES NOT SHOW ANY DEFICIENCIES AND THE LOG DATA ALSO GIVE NO REASON TO BELIEVE, THAT THE FLOW-BUBBLE-SENSOR WAS POSITIONED FALSELY PRIOR TO THE IMPLEMENTATION OF THE DISTAL REPERFUSION CANNULA. GIVEN THE INFORMATION OF THE CUSTOMER, THAT THE CARDIOHELP-I WAS RUNNING AT 3000RPM, WHEN CLAMPED THERE ARE SOME POSSIBLE SITUATIONS, CREATING A BACKFLOW. 1)SUDDEN CLAMPING OF LINES WHILE THE PUMP WAS ACTIVE. CLAMPING THE VENOUS OR ARTERIAL LINES WHILE THE PUMP IS STILL OPERATING CAN RESULT IN SUDDEN PRESSURE DIFFERENTIALS AND TURBULENT FLOW, POTENTIALLY LEADING TO TRANSIENT NEGATIVE PRESSURES AT THE INLET OR OUTLET. THIS MAY CAUSE CAVITATION OR CONDITIONS INTERPRETED BY THE SYSTEM AS RISK FOR BACKFLOW. 2)TRANSIENT LOSS OF PRELOAD DUE TO BLEEDING OR AIR IN THE CIRCUIT. SEVERE HYPOVOLEMIA OR ENTRAINMENT OF AIR DUE TO MASSIVE BLEEDING CAN LEAD TO LOSS OF VENOUS RETURN (PRELOAD) INTO THE PUMP HEAD. EVEN AT HIGH RPMS, THE LACK OF SUFFICIENT VOLUME WOULD RESULT IN FLOW COLLAPSE, POTENTIALLY TRIGGERING BACKFLOW PREVENTION. 3)INCOMPLETE OCCLUSION OF THE ARTERIAL LINE OR CANNULA MALPOSITION. IMPROPERLY POSITIONED OR PARTIALLY OCCLUDED ARTERIAL CANNULAS CAN REDUCE AFTERLOAD RESISTANCE IN THE CIRCUIT, POTENTIALLY ALLOWING FOR RETROGRADE FLOW OR SYSTEM INSTABILITY. AS THE CUSTOMER STATED THAT THEY CLAMPED BOTH LINES (VENOUS AND ARTERIAL, THIS SEEMS TO BE LESS POSSIBLE) 4) MASSIVE BLEEDING AND RAPID VOLUME SHIFTS LARGE, RAPID SHIFTS IN INTRAVASCULAR VOLUME CAN DESTABILIZE INLET PRESSURE, PARTICULARLY DURING ECMO SUPPORT. THIS MAY AFFECT PUMP HEAD DYNAMICS AND POTENTIALLY INTERFERE WITH THE FLOW SENSING SYSTEM, TRIGGERING PROTECTIVE RESPONSES. (THIS MAY HAVE TRIGGERED A LOWPRESSURE ALARM ON THE PVEN BUT IS NOT SHOWN IN THE LOG DATA) SEEMINGLY, THE MOST LIKELY ROOT CAUSE, ACCORDING TO THE DATA PROVIDED BY THE CUSTOMER, SERVICE TECHNICIAN, AND LOG DATA WAS THE SUDDEN CLAMPING OF LINES WHILE THE PUMP WAS ACTIVE AT HIGH RPM IN COMBINATION WITH THE PATIENT¿S UNDERLYING HYPOVOLEMIA FROM MASSIVE BLEEDING. IT IS ASSUMED THAT THIS COMBINATION LED TO A TRANSIENT INSTABILITY IN THE CIRCUIT PRESSURES, CONTRIBUTING AN ACTUAL BACKFLOW SITUATION IN WHICH THE CARDIOHELP-I PERFORMED AS INTENDED AND THE BACKFLOW PREVENTION WAS ACTIVATED. GIVEN THE DATA PROVIDED, NO DEFINITE ROOT CAUSE FOR THE ACTIVATION OF THE BACKFLOW PREVENTION CAN BE DRAWN. THE IFU DEFINES A BACKFLOW AS A NEGATIVE FLOW FOR MORE THAN 3 SECONDS, CAUSING A ¿BACKFLOW PREVENTION¿ ALARM AND ACTIVATION OF THE ZERO-FLOW MODE. BY ACTIVATING THE ZERO-FLOW MODE THE CARDIOHELP-I AIMS TO MAINTAIN A FLOW OF 0 L/MIN (SEE IFU GRABS BELOW). WHEN THE ZERO-FLOW MODE IS IN OPERATION, IT IS CRUCIAL TO FOLLOW THE APPROPRIATE PROCEDURE ALLOWING THE CARDIOHELP-I TO LEAVE THE MODE AND RESTART THE PERFUSION. THIS SPECIFIC PROCEDURE INCLUDES THE REDUCTION OF THE FLOWRATE TO ZERO, PRESSING THE SAFETY BUTTON, AS WELL AS THE ZERO-FLOW BUTTON. REVIEWING THE INFORMATION PROVIDED BY THE CUSTOMER, NO CLEAR CAUSE FOR THIS BACKFLOW COULD BE IDENTIFIED. ANOTHER POSSIBILITY LEADING TO A BACKFLOW PREVENTION ALARM FOLLOWING ZERO-FLOW MODE ACTIVATION MAY BE INCORRECT VALUES FROM THE FLOW/BUBBLE SENSOR OR THE LEVEL SENSOR. HOWEVER, THE INSPECTION BY GETINGE FIELD SERVICES SUGGESTS THAT DEVICE WAS IN PROPER WORKING ORDER. WHEN CONSIDERING THE WHOLE CLINICAL SITUATION, PROLONGED RESUSCITATION, ACUTE LAD-OCCLUSION AND STENT-IMPLANTATION, UNCONTROLLED SEVERE HEMORRHAGE, AND LOW LVEF, THE CUSTOMER WAS LIKELY CONFRONTED WITH A HIGHLY CRITICAL AND ILL PATIENT. IT APPEARS THE ONGOING EXSANGUINATION AND PRONOUNCES DIFFUSE COAGULOPATHY MAY HAVE BEEN COMPLICATING SUPPORT, LEADING TO THE EXPIRATION OF THE PATIENT. IN CONCLUSION, THE CARDIOHELP SYSTEM APPEARS TO HAVE FUNCTIONED WITHIN ITS INTENDED DESIGN THROUGHOUT THE EVENT. BASED ON THE AVAILABLE DATA AND POST-EVENT ANALYSIS, NO TECHNICAL MALFUNCTION WAS IDENTIFIED. THE ACTIVATION OF SAFETY FEATURES - SUCH AS THE BACKFLOW PREVENTION - WAS CONSISTENT WITH CARDIOHELP-I DESIGN AND SENSOR INPUT. IT IS POSSIBLE THAT THE CRITICAL CLINICAL CONDITION OF THE PATIENT, INCLUDING PROLONGED CARDIAC ARREST, ONGOING MASSIVE HEMORRHAGE, AND THE COMPLEXITY OF THE PROCEDURAL ENVIRONMENT, MAY HAVE CONTRIBUTED TO THE OBSERVED CIRCUIT INSTABILITY AND ULTIMATELY INFLUENCING THE CLINICAL OUTCOME." ACCORDING TO THE INSTRUCTION FOR USE (IFU) OF THE CARDIOHELP DEVICE (CHAPTER ¿HIGH PRIORITY¿) IT IS STATED THAT THIS ERROR MESSAGE INFORM THE USER OF AN ERROR THAT REQUIRE THE SERVICE TO DIAGNOSE THE FAULT. THE CARDIOHELP SHOULD BE EXCHANGED AS QUICKLY AS POSSIBLE, IF THE FAILURE OCCURS DURING PATIENT TREATMENT. THE PERFUSION ON THE CARDIOHELP SHOULD CONTINUALLY BE CHECKED, AS WELL AS THE MONITORING OF THE PATIENT. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-06-02 FOR THE PERIOD OF 2018-02-15 TO 2025-05-27. IT 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 DEVICE WAS MANUFACTURED ON 2018-02-15. 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. ACCORDING TO THE RISK REVIEW THE REPORTED FAILURE IS BELOW THE ACCEPTANCE THRESHOLD ACCORDING TO THE RISK MANAGEMENT PLAN OF THE CARDIOHELP DEVICE. BASED ON THE RESULTS THE REPORTED FAILURE "DEVICE DEFECTIVE ERROR" COULD BE CONFIRMED, BUT WAS NOT A DEVICE RELATED FAULT. THIS COMPLAINT WAS FOUND IN THE DATABASE OF CUSTOMER COMPLAINTS FOR THE CARDIOHELP DEVICE AS A SINGLE EVENT (TIMEFRAME FROM 2024-05-27 TILL 2025-05-27). 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 EVENT OCCURRED IN DENMARK DURING TREATMENT. IT WAS REPORTED THAT THE PATIENT ARRIVED IN THE HOSPITAL WITH A LUCAS PUMP PUMPING FOR ONE HOUR AND THE PATIENT HAS A CLOSED LEFT ANTERIOR DESCENDING (LAD). IT WAS HARD TO CANNULATE THE PATIENT AS THE PATIENT WAS BLEEDING ACCORDING TO THE CUSTOMER FROM ¿EVERYWHERE¿. THIS WAS CAUSED DUE TO THE LONG-TERM USE OF THE LUCAS PUMP. THE PATIENT WAS PUT ON ECMO. A CORONARY ARTERIOGRAPHY (KAG) WAS DONE AND THE LAD WAS OPENED. THE CUSTOMER WANTED TO DO A SMALL BYPASS WITH THE CANNULATION TO SECURE THE BLOOD FLOW TO THE LEG AND THEN THE STAFF CLAMPED THE HLS SET. A DEVICE DEFECTIVE ERROR MESSAGE OCCURRED, AS THE CUSTOMER HAS REMOVED THE SET WHILE THE PUMP WAS RUNNING. THE PATIENT WAS HAND CRANKED AND THE CARDIOHELP DEVICE WAS REPLACED. NEW INFORMATION WAS RECEIVED ON (B)(6) 2025 THAT THE PATIENT REMAINED FOR 3,5 HOURS ON THE REPLACED CARDIOHELP DEVICE BEFORE THE PATIENT PASSED AWAY. THE GETINGE SERVICE TECHNICIAN CONFIRMED THAT THERE WAS NO FAULT ON THE SECOND HARDWARE DEVICE NOR ON THE DISPOSABLE USED. THE PATIENT PASSED HAD MASSIVE BLEEDING, WHICH WAS BEFORE AND AFTER COMING ON ECMO. FURTHER IT WAS DIFFICULT TO CANNULATE THE PATIENT. THE PATIENT PASSED AWAY DUE TO BLEEDING AND LOW BLOOD PRESSURE. AS THE PATIENT PASSED AWAY AND THE CARDIOHELP DEVICE WAS REPLACED DURING TREATMENT, A REPORT IS REQUIRED. NEW INFORMATION RECEIVED ON (B)(6) 2025 THAT THE PATIENT DID NOT DIE DUE TO RELATED WRONG USER HANDLING ON THE DEVICE, BUT BECAUSE THE PATIENT WAS VERY SICK WHEN HE ARRIVED IN THE HOSPITAL. FURTHER THE LUCAS DEVICE WAS ON THE PATIENT FOR TWO HOURS AND LEAD TO A LOT IF INTERNAL BLEEDING. COMPLAINT ID# (B)(4).
COMPLAINT ID (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673606 | CARDIOHELP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | CARDIOHELP | 04037691658384 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Male | Death |