TUBING SET
Report
- Report Number
- 8010762-2025-0000383
- Event Type
- Malfunction
- Date Received
- September 3, 2025
- Report Date
- September 22, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- PMA / PMN Number
- K112360
- 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 THERE WAS A BLOOD LEAK AT THE ARTERIAL SAMPLING LINE (ARTERIAL BLOOD OUTLET). NO HARM TO ANY PERSON HAS BEEN REPORTED. NEW INFORMATION RECEIVED ON 2025-08-30 THAT THE AMOUNT OF BLOOD LEAKAGE IS UNKNOWN. THE SET WAS PRIMED AND CONNECTED TO THE PATIENT ON (B)(6) 2025. AS THERE WAS A BLOOD LEAKAGE DURING TREATMENT, A REPORT IS REQUIRED. AS THE AFFECTED PRODUCT WAS DISCARDED BY THE CUSTOMER, THE EXACT ROOT CAUSE REMAINS UNKNOWN. HOWEVER, A MEDICAL CONSULTATION WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON (B)(6) 2025 WITH FOLLOWING CONCLUSION: "BASED ON THE AVAILABLE INFORMATION, POTENTIAL ROOT CAUSES FOR THE LEAKAGE AT THE LUER LOCK OF THE HLS SET MAY INCLUDE: 1) IMPROPER CONNECTION OR HANDLING: THE LEAK MAY HAVE RESULTED FROM AN INCOMPLETE OR MISALIGNED CONNECTION AT THE OXYGENATOR PORT, POSSIBLY EXACERBATED BY TIME PRESSURE DURING THE EMERGENCY SETUP. 2) MECHANICAL STRESS OR TORQUE ON THE CONNECTOR: EXCESSIVE FORCE, TENSION, OR TWISTING OF THE TUBING DURING PRIMING OR SETUP COULD HAVE COMPROMISED THE INTEGRITY OF THE CONNECTION. 3) MANUFACTURING DEFECT: A LESS LIKELY BUT POSSIBLE CAUSE INCLUDES A DEFECT IN THE OXYGENATOR HOUSING, PORT, OR ACCESSORIES LIKE LUER LOCK STOPCOCK ETC. HOWEVER, BARRING A THOROUGH INSPECTION OF THE PRODUCT, THIS POSSIBLE ROOT CAUSE CANNOT BE DETERMINED. 4) DAMAGE DURING SHIPPING/ UNPACKING OR SETUP: ACCIDENTAL IMPACT, DURING UNPACKING OR INSTALLATION MAY HAVE INTRODUCED OR WORSENED THE DEFECT. POTENTIAL RISK TO PATIENT: 1) AIR EMBOLISM: A LEAK IN THE OXYGENATOR CONNECTION AREA, PARTICULARLY UNDER NEGATIVE PRESSURE, CAN INTRODUCE AIR INTO THE CIRCUIT WHICH MAY POSE OF THE RISK OF AIR EMBOLISM INTRODUCED TO THE PATIENT. 2) BLOOD LOSS OR HEMODYNAMIC INSTABILITY: DEPENDING ON THE SIZE AND LOCATION OF THE LEAK, THERE MAY BE A RISK OF BLOOD LOSS OR CIRCUIT FLOW INSTABILITY, WHICH COULD COMPROMISE OXYGENATION OR PERFUSION. THE COMPLAINT STATED THAT THE BLOOD LOSS WAS UNKNOWN; THEREFORE, ANY COMPLICATIONS ARISING FROM LOSS OF BLOOD CANNOT BE EXPANDED UP HERE. ALSO, HEMODYNAMIC INSTABILITY MAY RESULT IF THE PRODUCT REQUIRED EXCHANGE, CONTINGENT ON THE SUPPORT DEPENDENCY OF THE PATIENT. 3) INFECTION RISK: ONE PHOTOGRAPH SHOWED A TIE BAND ATTACHED TO THE CIRCUIT WHICH MAY HAVE EXACERBATED THE REPORTED LEAKING DUE TO MECHANICAL TORSION OF THE LUER. THAT SAID, IT IS ASSUMED THAT PATHOGENIC EXPOSURE DURING A LEAK MAY LEAD TO INFECTION. HOWEVER, INFECTIOUS CONVERSION DEPENDS ON PATHOGENIC LOAD AND EXPOSURE AS WELL AS IMMUNOLOGICAL FUNCTION/STATUS. 4)CIRCUIT COMPROMISE: CONTINUED USE OF A COMPROMISED ECMO SET, EVEN TEMPORARILY, MAY PRESENT AN UNEXPECTED DISCONNECTION OR WORSENING OF THE REPORTED LEAK UNDER PRESSURE IS POSSIBLE. NO DETAILS REGARDING PATIENT OUTCOME WERE SHARED IN THE CONTEXT OF THE COMPLAINT NARRATIVE. THEREFORE, ANY POSSIBLE CLINICAL ASSOCIATION BETWEEN THE OUTCOME OF THE PATIENT ON THE CITED EVENT IS NOT DETERMINABLE. MOREOVER, THE ABOVE POTENTIAL RISKS MAY ONLY BE DESCRIBED AS POTENTIAL RISKS." 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 (B)(6) 2025. 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 REGARD 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 REGARD TO THE REPORTED FAILURE. BASED ON THE RESULTS THE REPORTED FAILURE "SAMPLING LINE LEAKAGE" COULD BE CONFIRMED DUE TO THE PROVIDED PICTURES. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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. 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 THERE WAS A BLOOD LEAK AT THE ARTERIAL SAMPLING LINE (ARTERIAL BLOOD OUTLET). NO HARM TO ANY PERSON HAS BEEN REPORTED. NEW INFORMATION RECEIVED ON 2025-08-30 THAT THE AMOUNT OF BLOOD LEAKAGE IS UNKNOWN. THE SET WAS PRIMED AND CONNECTED TO THE PATIENT ON (B)(6) 2025. AS THERE WAS A BLOOD LEAKAGE DURING TREATMENT, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).
COMPLAINT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2331489 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET | 3000426592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female |