TUBING SET
Report
- Report Number
- 8010762-2025-0000154
- Event Type
- Death
- Date Received
- April 2, 2025
- Date of Event
- March 21, 2025
- Report Date
- July 10, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- UDI-DI
- 04058863005744
- PMA / PMN Number
- K112360
- Adverse Event
- Yes
- 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.
THE EVENT OCCURRED IN FRANCE DURING TREATMENT. IT WAS REPORTED THAT THE CIRCUIT WAS PRIMED WITH WATER IN ACCORDANCE WITH STANDARD PROCEDURES TO PREPARE FOR ECMO SUPPORT. THE FLOW RATE WAS OBTAINED WITHOUT DIFFICULTY. A FEW MINUTES LATER THERE WAS A LOSS OF FLOW, A MACHINE ALARM AND VISIBLE BUBBLES WITHIN THE OXYGENATOR. THE SYSTEM COULD NOT BE DE-AIRED. THE CIRCUIT WAS CLAMPED AND THE CIRCUIT REPLACED. THE PATIENT WAS ADMITTED FOR EMERGENCY CARDIAC ARREST. THE CARE WAS DELAYED FOR THIS PATIENT. THE ECMO WAS INITIATED AT 8 PM ON (B)(6) 2025 AND THE PATIENT PASSED AWAY AT 3 AM ON (B)(6) 2025. NEW INFORMATION WAS RECEIVED ON 2025-04-03 THAT THE PATIENT WAS CONNECTED TO THE FIRST HLS SET WHICH CONTAINED AIR IN THE SYSTEM. LATER, IT WAS CONFIRMED THAT THE REPLACEMENT SET HAD NO FAULT AND WAS DISCARDED BY THE CUSTOMER. THE FIRST SET WAS AVAILABLE FOR INVESTIGATION, WHICH ACCORDING TO THE CUSTOMER HAD NO VISIBLE DEFECT NOR ANY LEAKS DURING/AFTER PRIMING. FURTHER INFORMATION WAS RECEIVED THAT THERE WAS NO AIR ENTRY AFTER THE REPLACEMENT OF THE AFFECTED SET. THE USED CANNULAS WERE NOT REPLACED AND WERE THEREFORE WORKING AS EXPECTED. NO INFORMATION WAS AVAILABLE IF THE USED CANNULAS WERE GETINGE CANNULAS. THE CANNULAS WERE DISCARDED BY THE CUSTOMER. AS PATIENT DEATH WAS REPORTED, A REPORT IS REQUIRED. THE AFFECTED PRODUCT WAS INVESTIGATED BY THE GETINGE LABORATORY ON 2025-06-27 WITH FOLLOWING CONCLUSION: THE FAILURE COULD NOT BE CONFIRMED. THERE WERE NO VISIBLE DAMAGES ON THE PRODUCT. THE PRODUCT COULD BE PRIMED WITHOUT ANY PROBLEMS AND THERE WAS NO AIR ENTRY. THE PRODUCT FUNCTIONALITY WAS AS EXPECTED. A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON 2025-07-04 WITH FOLLOWING CONCLUSION: "ON (B)(6) 2025, AN INCIDENT OCCURRED INVOLVING AN HLS SET ADVANCED 7.0 USED WITH THE CARDIOHELP-I SYSTEM DURING VA-ECLS. THE PATIENT, A 45-YEAR-OLD FEMALE ADMITTED AFTER CARDIAC ARREST, RECEIVED ECLS SUPPORT BEGINNING AT APPROXIMATELY 20:15. WHILE INITIAL STARTUP WAS UNEVENTFUL AND TARGET FLOW WAS ACHIEVED, A SUDDEN LOSS OF FLOW OCCURRED SHORTLY THEREAFTER, ACCOMPANIED BY BUBBLE DETECTION ALARMS. AIR BUBBLES WERE OBSERVED IN THE OXYGENATOR AND COULD NOT BE REMOVED. NO AIR ENTRY SOURCE WAS IDENTIFIED AT THE TIME. THE CLINICAL TEAM REPLACED THE CIRCUIT, WHICH FUNCTIONED NORMALLY. THE PATIENT EXPIRED AT AROUND 03:00; NO DIRECT CAUSAL LINK TO THE INCIDENT WAS ESTABLISHED, THOUGH TREATMENT WAS DELAYED. THE SUBSEQUENT INVESTIGATION FOUND NO PRODUCT-RELATED DEFECTS. A MINOR LEAK AT THE VENOUS SAMPLING PORT WAS ATTRIBUTED TO DRIED BLOOD RESIDUE AND WAS NO LONGER PRESENT AFTER CLEANING. THE TUBING, INCLUDING THE CRITICAL VENOUS LINE, SHOWED NO DAMAGE OR KINKS. FUNCTIONAL TESTING, INCLUDING A 60-MINUTE LEAK TEST, CONFIRMED SYSTEM INTEGRITY. A PRESSURE SENSOR MALFUNCTION WAS NOTED BUT DETERMINED TO BE RELATED TO TRANSPORT AND NOT CONNECTED TO THE COMPLAINT. IMPORTANTLY, THE VENOUS CANNULA USED DURING ECMO INITIATION - A CRITICAL COMPONENT IN ASSESSING THE ROOT CAUSE OF AIR INGRESS - WAS NOT RETURNED FOR FURTHER EVALUATION. THIS OMISSION LIMITS THE ABILITY TO FULLY RULE OUT A CONNECTION-RELATED ISSUE OR A DEFECT AT THE INSERTION SITE. LITERATURE SUPPORTS THE RISK OF AIR INGRESS VIA THE VENOUS LINE OR CANNULA DURING ECMO, PARTICULARLY IN THE PRESENCE OF LOOSE CONNECTIONS, NEGATIVE PRESSURE, OR INSUFFICIENT PRIMING. IN ADDITION, AIR INGRESS THROUGH A CENTRAL VENOUS CATHETER, IF PRESENT, COULD BE A CONTRIBUTING FACTOR, PARTICULARLY IF CONNECTIONS WERE NOT FULLY SECURED. THE ASSUMPTION OF VENOUS AIR ENTRAINMENT APPEARS TO CONFORM TO THE EVENT PATTERN AS DESCRIBED: LOSS OF FLOW (DUE TO AIR INVASION OF THE CENTRIFUGAL PUMP), AIR IN THE OXYGENATOR, THEN BUBBLE ALARM. IT IS PRESUMED THAT THE REPORTED BUBBLE ALARM WAS ARTERIAL. NO MENTION OF VENOUS BUBBLE SENSOR DEPLOYMENT, HOWEVER, WAS CITED IN THE COMPLAINT NARRATIVE. IN CONCLUSION AND GIVEN THE ABSENCE OF THE VENOUS CANNULA FOR INVESTIGATION AND THE LIMITED PROCEDURAL DETAILS AVAILABLE, NO DEFINITIVE ROOT CAUSE OF THE AIR INGRESS CAN BE CONFIRMED. HOWEVER, POSSIBLE CAUSES INCLUDE A LEAK AT THE VENOUS CANNULA SITE, AIR ENTRY VIA A CENTRAL VENOUS CATHETER, OR A TRANSIENT LEAK AT THE VENOUS SAMPLING PORT, OBSERVED DURING INITIAL FLUSHING AND ATTRIBUTED TO DRIED BLOOD RESIDUES, THOUGH THIS WAS NOT REPRODUCIBLE UNDER CONTROLLED TESTING CONDITIONS." 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 2025-07-03. 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 AN 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 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. 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. IT WAS REPORTED THAT THE CIRCUIT WAS PRIMED WITH WATER IN ACCORDANCE TO STANDARD PROCEDURES TO PREPARE FOR ECMO SUPPORT. THE FLOW RATE WAS OBTAINED WITHOUT DIFFICULTY. A FEW MINUTES LATER THERE WAS A LOSS OF FLOW, A MACHINE ALARM AND VISIBLE BUBBLES WITHIN THE OXYGENATOR. THE SYSTEM COULD NOT BE DE-AIRED. THE CIRCUIT WAS CLAMPED AND THE CIRCUIT REPLACED. THE PATIENT WAS ADMITTED FOR EMERGENCY CARDIAC ARREST. THE CARE WAS DELAYED FOR THIS PATIENT. THE ECMO WAS INITIATED AT 8 PM AND THE PATIENT PASSED AWAY AT 3 AM. COMPLAINT ID# (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1264081 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET | 3000430696 | 04058863005744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female | Death |