TUBING SET
Report
- Report Number
- 8010762-2025-0000392
- Event Type
- Malfunction
- Date Received
- September 5, 2025
- Date of Event
- August 21, 2025
- Report Date
- January 8, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- UDI-DI
- 04058863005744
- PMA / PMN Number
- K112360
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE FRANCE MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HLS-SET¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K112360. 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 HLS SET WITH CATALOG NUMBER 701069073.
ADDITIONAL INFORMATION WAS RECEIVED ON 2025-12-15 THAT THE CUSTOMER USED A PRINTED PROTOCOL FOR PRIMING, WHICH IS UP TO DATE. THE CUSTOMER STATED THAT THE "NORMAL" NOISE IS COMING FROM THE DE-AIRING VALVE WHEN PRIMING IS STARTED. THE BUBBLE ALARM DID NOT STOP DESPITE IT WAS RESETTLED, AS BUBBLES WERE STILL DETECTED. THE CUSTOMER CONFIRMED THAT ALL PRIMING STEPS ACCORDING TO THE INSTRUCTION OF USE OF THE HLS SET WERE FOLLOWED AND THE POSITION OF THE FLOW BUBBLE SENSOR WAS CORRECTLY. A VENOUS BUBBLE SENSOR WAS NOT USED AS IT IS AN OPTIONAL BUBBLE SENSOR. NO DEVIATIONS WERE NOTED DURING THE PRIMING PROCESS. THE FIRST BUBBLE ALARM WAS DURING TREATMENT. FURTHER THE PATIENTS AGE WAS SHARED: 46 YEARS OLD. A FOLLOW UP INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 2025-12-19 THAT THE CUSTOMER FIRST CONNECTED A SAMPLE GAS LINE ON THE ARTERIAL QUICK VENT THAT DID NOT COME FROM A GETINGE KIT. THE THIRD-PARTY SAMPLE GAS LINE WAS THAN REPLACED BY THE CUSTOMER WITH A SAMPLING LINE FROM GETINGE. FURTHER IT WAS CONFIRMED BY THE CUSTOMER THAT THE AIR COULD NOT COME FROM A CENTRAL VENOUS CATHETER. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
FURTHER INFORMATION WAS RECEIVED THAT DURING EMERGENCY ECMO INITIATION AIR WAS DETECTED IN THE TEE. THE PATIENT REQUIRED ECMO DUE TO HYPOXEMIA WITH A SATURATION BETWEEN 40 AND 50%. DURING PRIMING PROCEDURE THE CUSTOMER NOTICED THAT THE THREE WAY STOPCOCK WAS WRONGLY POSITIONED AND WAS REPLACED. ADDITIONAL A NEW DE-AIRING TEST OF THE HLS SET WAS PERFORMED. 30 MINUTES LATER IT WAS DECIDED TO PUT THE PATIENT ON THE ECMO WHERE THE AIR WAS VISIBLE IN THE TEE. THE FLOW BUBBLE SENSOR RECOGNIZED AIR AND THE CUSTOMER STATED THAT THERE WAS VISIBLE AIR IN THE OXYGENATOR. THE FLOW WAS REDUCED TO 1,2 LITER PER MINUTES AND PATIENT WAS PUT INTO TRENDELENBURG-POSITION. THE PATIENT WAS PUT ON ANOTHER HLS SET. THE CUSTOMER CONFIRMED THAT AN EXPERIENCED NURSE WAS MISSING DURING DE-AIRING WHILE PRIMING THE HLS SET AND THE DIRECT INTERACTION BETWEEN DOCTOR AND NURSE DURING DE-AIRING WHILE PRIMING WAS ABSENT. FURTHER IT WAS CONFIRMED THAT THERE WAS LESS EXPERIENCE OF THE MEDICAL STAFF WITH ECMO. NEW INFORMATION WAS RECEIVED ON 2025-11-03 THAT THE PATIENT IS A MALE WITH A HEIGHT OF 162CM AND 45KG. THE WEIGHT FLUCTUATED AT THE TIME OF HIS CARE WITH MORE OR LESS -5KG. THE PATIENT LEFT THE INTENSIVE CARE UNIT AND WAS ADMITTED TO A FOLLOW-UP CARE AND REHABILITATION CENTER. ACCORDING TO THE RISK REVIEW THE REPORTED FAILURE IS BELOW THE ACCEPTANCE THRESHOLD ACCORDING TO THE RISK MANAGEMENT PLAN OF THE HLS SET. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE FRANCE MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HLS-SET¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K112360. 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 HLS SET WITH CATALOG NUMBER 701069073.
THE EVENT OCCURRED IN FRANCE DURING TREATMENT. IT WAS REPORTED THAT THE USER NOTICED AIR BUBBLES IN THE SYSTEM AND THE ARTERIAL FLOW BUBBLE SENSOR OF THE CARDIOHELP ALARMED. THE SET WAS PRIMED ON (B)(6) 2025 AND CONNECTED TO THE PATIENT. THERE WERE NO LEAKAGES DURING PRIMING PROCEDURE. THE FAILURE OCCURRED IMMEDIATELY AFTER STARTING TREATMENT. THE HLS SET WAS REPLACED. NO HARM TO ANY PERSON HAS BEEN REPORTED. FURTHER INFORMATION WAS RECEIVED THAT DURING EMERGENCY ECMO INITIATION AIR WAS DETECTED IN THE TEE. THE PATIENT REQUIRED ECMO DUE TO HYPOXEMIA WITH A SATURATION BETWEEN 40 AND 50%. DURING PRIMING PROCEDURE, THE CUSTOMER NOTICED THAT THE THREE-WAY STOPCOCK WAS WRONGLY POSITIONED AND WAS REPLACED. ADDITIONALLY, A NEW DE-AIRING TEST OF THE HLS SET WAS PERFORMED. 30 MINUTES LATER IT WAS DECIDED TO PUT THE PATIENT ON THE ECMO WHERE THE AIR WAS VISIBLE IN THE TEE. THE FLOW BUBBLE SENSOR RECOGNIZED AIR AND THE CUSTOMER STATED THAT THERE WAS VISIBLE AIR IN THE OXYGENATOR. THE FLOW WAS REDUCED TO 1,2 LITER PER MINUTES AND PATIENT WAS PUT INTO TRENDELENBURG-POSITION. THE PATIENT WAS PUT ON ANOTHER HLS SET. THE CUSTOMER CONFIRMED THAT AN EXPERIENCED NURSE WAS MISSING DURING DE-AIRING WHILE PRIMING THE HLS SET AND THE DIRECT INTERACTION BETWEEN DOCTOR AND NURSE DURING DE-AIRING WHILE PRIMING WAS ABSENT. FURTHER IT WAS CONFIRMED THAT THERE WAS LESS EXPERIENCE OF THE MEDICAL STAFF WITH ECMO. NEW INFORMATION WAS RECEIVED ON 2025-11-03 THAT THE PATIENT IS A MALE WITH A HEIGHT OF 162CM AND 45KG. THE WEIGHT FLUCTUATED AT THE TIME OF HIS CARE WITH MORE OR LESS -5KG. THE PATIENT LEFT THE INTENSIVE CARE UNIT AND WAS ADMITTED TO A FOLLOW-UP CARE AND REHABILITATION CENTER. ADDITIONAL INFORMATION WAS RECEIVED ON 2025-12-15 THAT THE CUSTOMER USED A PRINTED PROTOCOL FOR PRIMING, WHICH IS UP TO DATE. THE CUSTOMER STATED THAT THE "NORMAL" NOISE IS COMING FROM THE DE-AIRING VALVE WHEN PRIMING IS STARTED. THE BUBBLE ALARM DID NOT STOP DESPITE IT WAS RESETTED, AS BUBBLES WERE STILL DETECTED. THE CUSTOMER CONFIRMED THAT ALL PRIMING STEPS ACCORDING TO THE IFU WERE FOLLOWED AND THE POSITION OF THE FLOW BUBBLE SENSOR WAS CORRECTLY. A VENOUS BUBBLE SENSOR WAS NOT USED AS IT IS AN OPTIONAL BUBBLE SENSOR. NO DEVIATIONS WERE NOTED DURING THE PRIMING PROCESS. THE FIRST BUBBLE ALARM WAS DURING TREATMENT. FURTHER THE PATIENTS AGE WAS SHARED: 46 YEARS OLD. A FOLLOW UP INFORMATION WAS RECEIVED FROM THE CUSTOMER ON (B)(6) 2025 THAT THE CUSTOMER FIRST CONNECTED A SAMPLE GAS LINE ON THE ARTERIAL QUICK VENT THAT DID NOT COME FROM A GETINGE KIT. THE THIRD-PARTY SAMPLE GAS LINE WAS THAN REPLACED BY THE CUSTOMER WITH A SAMPLING LINE FROM GETINGE. FURTHER IT WAS CONFIRMED BY THE CUSTOMER THAT THE AIR COULD NOT COME FROM A CENTRAL VENOUS CATHETER. AS THERE WAS AIR IN THE SYSTEM DURING TREATMENT AND THE HLS SET WAS REPLACED, A REPORT IS REQUIRED. THE AFFECTED PRODUCT COULD NOT BE RETURNED FOR TECHNICAL INVESTIGATION. ACCORDING TO THE GETINGE SERVICE AND SALES SUPPORT THE CAUSE IS AN ISSUE WITH THE CARRIER. GETINGE WAS ABLE TO SEND THE BIOCONTAINER KIT TO THE CUSTOMER, BUT HAS NOT SUCCEEDED IN ORGANIZING THE RETURN FROM NEW CALEDONIA (ISLAND NEAR AUSTRALIA, COUNTING TO FRANCE), DESPITE SEVERAL ATTEMPTS WITH THE CARRIER USING DIFFERENT SOLUTIONS. THEREFORE THE EXACT ROOT CAUSE REMAINS UNKNOWN. HOWEVER, A MEDICAL CONSULTATION WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON 2025-12-22 WITH FOLLOWING CONCLUSION: "BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND THE IFU REQUIREMENTS, THE EVENT INVOLVED AIR ENTERING THE ECMO CIRCUIT DURING AN EMERGENCY VV ECMO IMPLANTATION. SUBSEQUENTLY, AIR-GAS EMBOLUS/EMBOLI WAS/WERE DETECTED IN THE RIGHT HEART IMMEDIATELY AFTER ¿CONNECTION¿. THE MEANING OF ¿CONNECTION¿ VERSUS ¿INITIATION¿ IN THE CONTEXT OF THE COMPLAINT NARRATIVE REMAINS UNCLEAR. THAT SAID, IT IS CHALLENGING TO DETERMINE HOW AIR MAY HAVE BEEN PRESENT AFTER ¿CONNECTION¿, BUT BEFORE ¿INITIATION¿ OF SUPPORT. THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED DUE TO LIMITED DATA AND THE ABSENCE OF PRODUCT INVESTIGATION. WHILE THE CUSTOMER REPORTED ADHERENCE TO THE IFU AND NO DEVIATIONS DURING PREPARATION, CERTAIN PROCEDURAL DETAILS REMAIN UNCLEAR AND WILL NOT BE PROVIDED, AS CONFIRMED BY THE SSU. THESE INCLUDE THE NATURE OF THE NOISE DURING START-UP, VERIFICATION OF EFFECTIVE PRIMING, CONSOLE POSITIONING, AND POST-EVENT CLINICAL FOLLOW-UP. THE EVENT MAY HAVE PRESENTED A SIGNIFICANT RISK TO THE PATIENT, ALTHOUGH NO HARM WAS REPORTED. THE REPORTED EVENT REQUIRED IMMEDIATE CORRECTIVE ACTION AND THE USE OF A SECOND ECMO SET ACCORDING TO THE CUSTOMER WHICH, APPARENTLY, SERVED AS A MITIGATION/REMEDIATION OF THE REPORTED EVENT. POSSIBLE ROOT CAUSES -INITIAL USE OF A NON KIT SAMPLING LINE CONNECTED TO THE ARTERIAL QUICK VENT. ¿RESIDUAL AIR RELATED TO STOPCOCK MISPOSITIONING¿ / ¿INCOMPLETE DE-AIRING AFTER CIRCUIT MODIFICATION¿ - THE INCORRECTLY POSITIONED 3-WAY STOPCOCK MAY HAVE ALLOWED AIR INGRESS OR INCOMPLETE AIR REMOVAL, PARTICULARLY IF THE CORRECTIVE ACTIONS WERE NOT FOLLOWED BY A CLEARLY CONFIRMED FUNCTIONAL BUBBLE DETECTION TEST.-A POTENTIAL DEVICE DEFECT/NONCONFORMANCE. HOWEVER, AS THE PRODUCT INVESTIGATION CANNOT BE PERFORMED, THIS CANNOT BE DETERMINED. -INCOMPLETE VERIFICATION OF PRIMING EFFECTIVENESS AND/OR LACK OF CLARITY ON THE MEMBRANE NOISE DURING START UP. " ACCORDING TO THE INSTRUCTION OF USE OF THE HLS SET IT IS MENTIONED THAT INCORRECT POSITIONING OF THE CARDIOHELP CAN CAUSE AIR PERMEATION ON THE BLOOD SIDE OF THE HLS MODULE ADVANCED. THE CARDIOHELP MUST BE POSITIONED AT A LEVER LOWER THAT THE PATIENT AND SECURED CLOSE TO THE PATIENT. THE FLOW-BUBBLE SENSOR MUST ALWAYS BE AFFIXED ON THE ARTERIAL SIDE OF THE SET IF YOU ARE USING THE CARDIOHELP-I. WITH AN ACTIVATED INTERVENTION, THE DETECTION OF BUBBLES BY THE FLOW/BUBBLE SENSOR TRIGGERS A PUMP STOP. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2025-12-31. ACCORDING TO THE FINAL TEST RESULTS, THE PRODUCT PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE REVIEW OF SCRAP, REWORK, ENHANCEMENTS AND DESIGN CHANGES WERE REVIEWED AND NO ABNORMALITIES IN REGARDS TO THE REPORTED FAILURE WERE FOUND. 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 REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED FOR THE REVIEWED TIME PERIOD. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARDS TO THE REPORTED FAILURE. BASED ON THE RESULTS THE REPORTED FAILURE "AIR IN SYSTEM" COULD NOT BE CONFIRMED. 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. ACCORDING TO THE RISK REVIEW THE REPORTED FAILURE IS BELOW THE ACCEPTANCE THRESHOLD ACCORDING TO THE RISK MANAGEMENT PLAN OF THE HLS SET. 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 FRANCE DURING TREATMENT. IT WAS REPORTED THAT THE USER NOTICED AIR BUBBLES IN THE SYSTEM AND THE ARTERIAL FLOW BUBBLE SENSOR OF THE CARDIOHELP ALARMED. THE SET WAS PRIMED ON (B)(6) 2025 AND CONNECTED TO THE PATIENT. THERE WERE NO LEAKAGES DURING PRIMING PROCEDURE. THE FAILURE OCCURRED IMMEDIATELY AFTER STARTING TREATMENT. THE HLS SET WAS REPALCED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THERE WAS AIR IN THE SYSTEM DURING TREATMENT AND THE HLS SET WAS REPLACED, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).
COMPLAINT ID: (B)(4).
COMPLAINT ID (B)(4).
COMPLAINT ID#: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1975543 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS-SET | 04058863005744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Male |