TUBING SET
Report
- Report Number
- 8010762-2025-0000324
- Event Type
- Death
- Date Received
- July 29, 2025
- Date of Event
- July 21, 2025
- Report Date
- November 14, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- UDI-DI
- 04058863005744
- PMA / PMN Number
- K112360
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 CHINESE 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 CHINA DURING TREATMENT. IT WAS REPORTED THAT A PATIENT WAS CONNECTED TO THE ECMO DUE TO CARDIOGENIC DISEASE. THERE WAS A LEAKAGE ON THE DEVICE AFTER APPROXIMATELY FORTY MINUTES AFTER INITIATION OF PERFUSION. THE LEAKAGE LOCATION WAS THE WHITE HEPARIN CAP (QUICK VENT LUER LOCK). THE HEPARIN CAP WAS CHANGED BUT THERE WAS STILL A LEAKAGE. THE CUSTOMER SUSPECTED THAT THE CONNECTOR WAS CRACKED. THE HLS SET WAS REMOVED. THE PATIENT PASSED WHILE NOT ON THE DEVICE. NEW INFORMATION RECEIVED ON 2025-08-07 THAT APPROXIMATELY 50 ML WITHIN 10 MINUTES OF BLOOD WAS LOST DUE TO THE LEAKAGE. THE SET WAS PRIMED AND CONNECTED TO THE PATIENT ON (B)(6) 2025. THERE WAS NO BLOOD TRANSFUSION REQUIRED DUE TO THE LEAKAGE. AFTER THE LEAKAGE WAS DISCOVERED A CAP FROM A THIRD PARTY COMPANY WAS USED TO CLOSE THE LUER. THE PATIENT PASSED ON (B)(6) 2025. IT WAS CONFIRMED THAT THE PATIENT PASSED DUE TO HIS DISORDERS (ILLNESS). ACCORDING TO THE CUSTOMER STATEMENTS, NO LEAKAGE WAS OBSERVED DURING OR IMMEDIATELY AFTER THE PRIMING PROCESS. THE ISSUE WAS REPORT TO HAVE OCCURRED APPROXIMATELY FORTY MINUTES AFTER INITIATION OF PERFUSION. THIS TIMELINE SUGGESTS THAT THE LEAKAGE WAS MORE LIKELY CAUSED BY OVERTIGHTENING AND/ OR MECHANICAL OVERLOAD OF THE LUER LOCK CONNECTION RATHER THAN AN IMMEDIATE ASSEMBLY DEFECT. THE PATIENT PASSED. AS THE HLS SET WAS REPLACED DURING USE DUE TO A REPORTED LEAKAGE, A REPORT IS REQUIRED. THE AFFECTED PRODUCT WAS INVESTIGATED IN THE GETINGE LABORATORY ON 2025-11-06 WITH FOLLOWING CONCLUSION: THE REPORTED FAILURE "LEAKAGE QUICK VENT LUER LOCK" COULD BE CONFIRMED. DURING VISUAL INSPECTION A CRACK ON THE LUER WAS OBSERVED, AS WELL AS THE USAGE OF THIRD-PARTY ACCESSORIES. THE EXACT ROOT CAUSE OF THE CRACK REMAINS UNDETERMINED. THE MOST PROBABLE ROOT CAUSES ARE: - ROUGH HANDLING DUE TO HIGH MOUNTING FORCE ON CUSTOMER SIDE - CONNECTION OF NON COMPATIBLE THIRD PARTY ACCESSORIES ON CUSTOMER SIDE THESE CAUSES WERE NOT CONFIRMED. A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON 2025-11-13 WITH FOLLOWING CONCLUSION: "BASED ON THE AVAILABLE INFORMATION FROM THE COMPLAINT, INVESTIGATION, AND CUSTOMER CORRESPONDENCE, A DEFINITIVE ROOT CAUSE FOR THE REPORTED LEAKAGE COULD NOT BE CONCLUSIVELY IDENTIFIED. THE INVESTIGATION OF THE RETURNED HLS SET 7.0 CONFIRMED A CRACK AT THE QUICK-VENT LUER CONNECTION AS THE PHYSICAL SOURCE OF THE LEAK. HOWEVER, THE SPECIFIC UNDERLYING CAUSE OF THIS CRACK REMAINS UNDETERMINED. REASONABLE AND POSSIBLE ROOT CAUSES INCLUDE MECHANICAL OVERLOAD RESULTING FROM THE INSTALLATION OF A NON-DIMENSIONALLY ACCURATE OR OVERLY TIGHT (THIRD-PARTY) LUER CAP, THAT MAY HAVE PREDISPOSED THE COMPONENT TO CRACKING UNDER APPLIED TORQUE. A COMBINATION OF THESE FACTORS CANNOT BE EXCLUDED. THE EVENT INVOLVED LEAKAGE CAUSED BY THE CRACKED LUER CONNECTOR. THIS GETINGE INVESTIGATION CORRESPONDED WITH THE CLINICAL OBSERVATION OF BLOOD LEAKAGE DURING TREATMENT. THE REPORTED LEAKAGE RESULTED IN A TEMPORARY LOSS OF PRODUCT INTEGRITY AND PERFORMANCE BUT WAS PROMPTLY IDENTIFIED AND MANAGED BY THE CLINICAL TEAM. NO EVIDENCE WAS FOUND OF A USE ERROR THAT DIRECTLY CAUSED OR CONTRIBUTED TO THE CRACK IN THE LUER CONNECTION. HOWEVER, THE USE OF A NON-GETINGE (THIRD-PARTY) ¿HEPARIN CAP¿/ QUICK-VENT LUER LOCK CAP AT THE AFFECTED INTERFACE WAS DOCUMENTED AND IS CONSIDERED A POTENTIAL CONTRIBUTING FACTOR TO THE MECHANICAL STRESS THAT LED TO THE DAMAGE. THE AVAILABLE DATA DO NOT INDICATE THAT USE OR PROCEDURAL ERROR DURING SETUP OR PRIMING AS THE PRIMARY CAUSE OF THE EVENT. THAT SAID, A USE ERROR CANNOT BE EXCLUDED AS A POSSIBLE ROOT CAUSE. ACCORDING TO THE CUSTOMER STATEMENTS, NO LEAKAGE WAS OBSERVED DURING OR IMMEDIATELY AFTER THE PRIMING PROCESS. THE ISSUE WAS REPORT TO HAVE OCCURRED APPROXIMATELY FORTY MINUTES AFTER INITIATION OF PERFUSION. THIS TIMELINE SUGGESTS THAT THE LEAKAGE WAS MORE LIKELY CAUSED BY OVERTIGHTENING AND/ OR MECHANICAL OVERLOAD OF THE LUER LOCK CONNECTION RATHER THAN AN IMMEDIATE ASSEMBLY DEFECT. THE IFU OF THE HLS SET CONTAIN THE WARNING "LEAKS AND DAMAGE ON THE DEVICE CAN LEAD TO INFECTIONS, BLOOD LOSS AND EMBOLISMS IN THE PATIENT. CHECK THE DEVICE FOR LEAKS DURING PRIMING, DO NOT USE THE DEVICE IF THERE ARE ANY LEAKS AND DO NOT USE THE DEVICE IF THE SURFACE OF THE MEASURING CELL IS DAMAGED". IN THIS CONTEXT, IF ANY LEAKAGE HAD BEEN PRESENT BEFORE OR DURING PRIMING, THE DEVICE SHOULD NOT HAVE BEEN USED IN ACCORDANCE WITH THE IFU REQUIREMENTS. HOWEVER, SINCE NO LEAKAGE WAS DETECTED AT THAT STAGE ACCORDING TO THE USER¿S ACCOUNT, IT IS MORE PLAUSIBLE THAT THE CRACK DEVELOPED SOME TIME AFTER PRIMING AND INITIATION, POTENTIALLY AS A RESULT OF MECHANICAL OVERLOAD OR STRESS AT THE LUER INTERFACE. THE PATIENT WAS A 60-YEAR-OLD MALE WITH A SEVERE CARDIOGENIC CONDITION AND CARDIAC AND RESPIRATORY ARREST, REQUIRING VA-ECC SUPPORT. ACCORDING TO THE GIVEN CLINICAL DATA OF THE PATIENT IT CAN BE ASSUMED THAT THE GENERAL CLINICAL SITUATION WAS CRITICAL, AND THAT SIGNIFICANT COMORBIDITY MAY HAVE BEEN PRESENT. ACCORDING TO THE COMPLAINT NARRATIVE AND THE CUSTOMER CORRESPONDENCE, THE PATIENT EXPIRED DUE TO THE UNDERLYING DISEASE RATHER THAN THE LEAKAGE OF THE DEVICE. THERE IS NO EVIDENCE OF A CAUSAL RELATIONSHIP BETWEEN THE DESCRIBED DEVICE MALFUNCTION AND THE PATIENT¿S EXPIRATION. THE LEAKAGE RESULTED IN AN ESTIMATED BLOOD LOSS OF APPROXIMATELY 50 MILLILITERS WITHIN TEN MINUTES. NO REPORT OF TRANSFUSION, OR OTHER MEDICAL INTERVENTION BEYOND REMOVAL OF THE DEVICE, WAS MENTIONED IN THE NARRATIVE. THE HAZARDOUS SITUATION LEADING TO THE EVENT WAS THE LOSS OF FLUID INTEGRITY DUE TO A CRACK IN THE QUICK-VENT LUER CONNECTION, WHICH ALLOWED BLOOD LEAKAGE FROM THE PRODUCT. THE HARM ASSOCIATED WITH THIS SITUATION WAS MINOR BLEEDING LIMITED TO APPROXIMATELY 50 MILLILITERS, WITHOUT APPARENT DIRECT CLINICAL CONSEQUENCE TO THE PATIENT, USER, OR THIRD PARTIES. THEREFORE, THERE IS NO EVIDENCE OF A DIRECT OR CONTRIBUTING LINK BETWEEN THE REPORTED MALFUNCTION AND THE PATIENT¿S EXPIRATION, WHICH WAS ATTRIBUTED TO THE EXISTING CRITICAL CARDIAC CONDITION. IN SUMMARY, A LEAK OCCURRED DUE TO A CRACKED QUICK-VENT LUER CONNECTION OF THE HLS SET 7.0 WHICH WAS CONFIRMED BY INVESTIGATION. THE CRACK¿S DEFINITIVE CAUSE REMAINS UNDETERMINED, WITH MECHANICAL OVERLOAD AND MATERIAL STRESS IDENTIFIED AS REASONABLE POTENTIAL CAUSES. THE EVENT REPRESENTED A CONFIRMED DEVICE MALFUNCTION BUT DID NOT RESULT IN DEVICE-RELATED PATIENT HARM OR DEMONSTRATE A CAUSAL RELATIONSHIP TO THE PATIENT¿S EXPIRATION, WHICH WAS CONFIRMED BY THE CUSTOMER." AS STATED IN THE INSTRUCTIONS FOR USE OF THE HLS SET - IN CHAPTER PREPARATION AND INSTALLATION ¿PERFORM A CAREFUL VISUAL INSPECTION OF THE DEVICE BEFORE USE. IN PARTICULAR, ENSURE THERE IS NO DAMAGE TO THE MATERIAL, CRACKS, BURRS OR FISSURES.¿ FURTHERMORE, IT IS STATED IN CHAPTER PRIMING THE SYSTEM ¿CHECK THE DEVICE FOR LEAKS DURING PRIMING. DO NOT USE THE DEVICE IF THERE ARE ANY LEAKS.¿ AND ¿BEFORE PRIMING THE SET, RUN WATER THROUGH THE HEAT EXCHANGER OF THE HLS MODULE ADVANCED AND CHECK FOR LEAKS.¿ ACCORDING TO THE INSTRUCTION FOR USE (IFU, HLS SET ADVANCED 6.0/7.0, HIT SET ADVANCED 5.0/7.0) IT IS STATED IN CHAPTER ¿SAFETY INSTRUCTIONS FOR CENTRIFUGAL PUMP¿ THAT LEAKS OR SCRATCHING NOISES IN THE CENTRIFUGAL PUMP CAN BE A SIGN THAT IT IS MALFUNCTIONING. MALFUNCTIONING CAN LEAD TO INADEQUATE PATIENT SUPPORT. FURTHERMORE IT IS MENTIONED TO ALWAYS KEEP A REPLACEMENT HLS SET FOR THOSE SITUATIONS. IN CHAPTER ¿PRIMING THE SYSTEM¿ IT IS WRITTEN NOT TO PRE-PRIME THE CIRCUIT TOO EARLY AS THIS COULD LEAD TO LEAKS AND TO NOT USE A DEVICE IF THERE ARE ANY LEAKS. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2025-11-13. 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 "QUICK VENT LUER LOCK LEAKAGE" COULD BE CONFIRMED, BUT WAS NOT RELATED TO THE PATIENTS DEATH. IT WAS CONFIRMED BY THE CUSTOMER THAT THE PATIENT PASSED DUE TO HIS DISORDERS (ILLNESS). 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.
NEW INFORMATION RECEIVED THAT APPROXIMATELY 50 ML WITHIN 10 MINUTES OF BLOOD WAS LOST DUE TO THE LEAKAGE. THE SET WAS PRIMED AND CONNECTED TO THE PATIENT ON (B)(6) 2025. THERE WAS NO BLOOD TRANSFUSION REQUIRED DUE TO THE LEAKAGE. AFTER THE LEAKAGE WAS DISCOVERED A CAP FROM A THIRD PARTY COMPANY WAS USED TO CLOSE THE LUER. THE PATIENT PASSED ON (B)(6) 2025. IT WAS CONFIRMED THAT THE PATIENT PASSED DUE TO HIS DISORDERS (ILLNESS). THE AFFECTED PRODUCT WAS INVESTIGATED IN THE GETINGE LABORATORY ON 2025-11-06 WITH FOLLOWING CONCLUSION: THE REPORTED FAILURE "LEAKAGE QUICK VENT LUER LOCK" COULD BE CONFIRMED. DURING VISUAL INSPECTION A CRACK ON THE LUER WAS OBSERVED, AS WELL AS THE USAGE OF THIRD-PARTY ACCESSORIES. THE EXACT ROOT CAUSE OF THE CRACK REMAINS UNKNOWN. THE MOST PROBABLE ROOT CAUSES ARE: ROUGH HANDLING DUE TO HIGH MOUNTING FORCE ON CUSTOMER SIDE - CONNECTION OF NON-COMPATIBLE THIRD PARTY ACCESSORIES ON CUSTOMER SIDE. 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 "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 CHINA DURING TREATMENT. IT WAS REPORTED THAT A PATIENT WAS CONNECTED TO THE ECMO DUE TO CARDIOGENIC DISEASE. A LEAKAGE ON THE QUICK VENT LUER CONNECTOR WAS REPORTED. THE CONNECTOR CAP WAS REPLACED BUT NOT SOLVED THE LEAKAGE. THE PATIENT PASSED WHILE NOT ON THE DEVICE. DUE TO THE LEAKAGE DURING USE AND THE HLS SET REPLACEMENT, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).
COMPLAINT ID# (B)(4).
COMPLAINT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1411904 | TUBING SET | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | HLS SET | 3000449041 | 04058863005744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Death |