TUBING SET
Report
- Report Number
- 3013876692-2025-00063
- Event Type
- Injury
- Date Received
- July 31, 2025
- Report Date
- August 27, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- UDI-DI
- 04058863078298
- PMA / PMN Number
- K112360
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor 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 CHINA 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 701069076.
THE EVENT OCCURRED IN CHINA DURING TREATMENT. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT WENT ON THE MACHINE AROUND 4 P.M. ONE HOUR LATER THE NURSE FOUND A SMALL NUMBER OF BUBBLES ABOVE THE OXYGENATOR MEMBRANE. THE MACHINE WAS SHUT DOWN AND THE BUBBLES WERE ELIMINATED. HOWEVER, LATER AT AROUND 10 P.M. THE NURSE FOUND THAT THE BLOOD FLOW DECREASED AND A LARGE NUMBER OF SMALL BUBBLES APPEARED IN THE ENTIRE SET. THE PATIENT'S OXYGEN SATURATION CONTINUED TO DECREASE. THE HLS SET WAS REPLACED. AS OF 8 A.M. ON (B)(6) 2025, THE PATIENT SIGNS ARE CURRENTLY STABLE. NEW INFORMATION RECEIVED ON 2025-07-28, THAT DURING PRIMING PROCEDURE NO BUBBLES WERE SEEN AND THE ENTIRE HLS KIT USAGE PROCESS AND METHOD ARE IN ACCORDANCE WITH GETINGE INSTRUCTIONS. THE PATIENT IS CURRENTLY STABLE. AS THE HLS SET WAS REPLACED, A REPORT IS REQUIRED. THE EXACT ROOT CAUSE REMAINS UNKNOWN, AS THE PRODUCT WAS DISCARDED BY THE CUSTOMER. A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS WITH FOLLOWING CONCLUSION: "THE DATA PROVIDED RELATES TO A CUSTOMER COMPLAINT INVOLVING AN ECC PROCEDURE PERFORMED ON (B)(6) 2025, USING A CARDIOHELP SYSTEM IN COMBINATION WITH AN HLS SET ADVANCED 5.0 AND HICO 660 HEATER/COOLER. THE PATIENT WAS 75 YEARS OLD, WEIGHED 59 KG, AND WAS PLACED ON ECC SUPPORT AT APPROXIMATELY 16:30 FOLLOWING UNEVENTFUL PRIMING. DURING THE PROCEDURE, TWO SEPARATE BUBBLE-RELATED INCIDENTS OCCURRED: THE FIRST AT APPROXIMATELY 17:00, WHEN A SMALL AMOUNT OF BUBBLES WAS DETECTED ABOVE THE OXYGENATOR MEMBRANE, LEADING TO A TEMPORARY SYSTEM SHUTDOWN OF UNKNOWN DURATION AND UNCLEAR CLINICAL IMPACT; AND THE SECOND AT APPROXIMATELY 22:00, WHEN SIGNIFICANT AIR INGRESS WAS OBSERVED WITHIN THE CIRCUIT, INCLUDING IN A COMPONENT REFERRED TO AS THE ¿5050 BAG¿. BASED ON THE AVAILABLE INFORMATION, IT IS ASSUMED THAT THIS REFERENCE TO THE ¿5050 BAG¿ WAS A TRANSLATION ISSUE AND THAT IT ACTUALLY REFERRED TO THE ENTIRE 5050 HLS SET., AS THE CUSTOMER¿S CLARIFICATION IN THE QUESTIONNAIRE ONLY INDICATED THE LOCATION OF BUBBLES IN THE CIRCUIT WITHOUT FURTHER DESCRIPTION OF THE COMPONENT ¿5050 BAG¿ ITSELF. THIS SECOND EVENT COINCIDED WITH REDUCED BLOOD FLOW AND DECLINING OXYGEN SATURATION. ACCORDING TO THE CUSTOMER THE HLS SET WAS URGENTLY REPLACED, AFTER WHICH NO FURTHER ABNORMALITIES OCCURRED. VIDEOS AND PHOTOGRAPHS SUBMITTED BY THE CUSTOMER CONFIRMED SEVERE AIR INGRESS INTO VENOUS AND ARTERIAL LINES AS WELL AS THE OXYGENATOR. THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED FOR FURTHER INVESTIGATION. THE PATIENT STABILIZED AFTER INTERVENTION AND WAS REPORTED IN GOOD CONDITION AT THE END OF TREATMENT. AIR INGRESS INTO A CLOSED ECMO SYSTEM, AS OBSERVED IN THIS INCIDENT, REPRESENTS A CRITICAL SAFETY CONCERN BECAUSE IT CAN LEAD TO REDUCED CIRCUIT PERFORMANCE, IMPAIRED OXYGENATION, AND POTENTIAL EMBOLIC COMPLICATIONS. PUBLISHED LITERATURE IDENTIFIES SEVERAL POTENTIAL MECHANISMS FOR SUCH OCCURRENCES IN CLOSED-LOOP SYSTEMS, INCLUDING, EXCESSIVE NEGATIVE PRESSURE IN THE VENOUS LINE CAUSING AIR ENTRAINMENT AND/OR CAVITATION. UNSECURED CONNECTIONS OR MICRO-LEAKS. INADVERTENT INTRODUCTION OF AIR THROUGH ACCESS POINTS LIKE OPEN PERIPHERAL CANNULA SITE, OR A FRACTURE OF A CONNECTOR ON THE INLET SIDE OF THE PUMP DURING INTERVENTIONS. VULNERABILITIES IN THE MEMBRANE OXYGENATOR UNDER PRESSURE CHANGES. ENTRAINMENT OR INADVERTENT INFUSION OF MICROBUBBLES FROM EXTERNAL LINES AND/OR SAMPLING LINES/ THREE-WAY STOP COCKS. POTENTIAL AIR ENTRY VIA A CENTRAL VENOUS CATHETER IF PRESENT. STRUCTURE PERFORATION OF THE VASCULAR SYSTEM DUE TO CANNULA MIGRATION MAY BE A POTENTIAL SOURCE OF AIR ENTRAINMENT. BASED ON THE DATA AVAILABLE AN EXACT ROOT CAUSE OF AIR INGRESSION CANNOT BE DEFINITIVELY IDENTIFIED. REASONABLE AND POSSIBLE CONTRIBUTING FACTORS ARE LISTED ABOVE AND ARE KNOWN CONTRIBUTORS OF AIR INGRESSION INTO AN ECMO CIRCUIT IN THE LITERATURE. THE CUSTOMER STATED THAT THERE WERE NO ISSUES WITH PRODUCT INTEGRITY, AND NO SPECIFIC POSITION OF AIR INGRESSION ON THE PRODUCT WAS REPORTED. AS THE AFFECTED PRODUCT IS NOT AVAILABLE FOR FURTHER INVESTIGATION BY GETINGE, A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE GIVEN DATA PRESENTED HERE. THEREFORE, DEVICE MALPERFORMANCE CAN NEITHER BE ASSUMED NOR DISCOUNTED FROM THE AVAILABLE INFORMATION PROVIDED. THE PATIENT, A 75-YEAR-OLD WITH UNDERLYING COMORBIDITIES, EXPERIENCED TRANSIENT DECREASED OXYGENATION AND REDUCED BLOOD FLOW DUE TO THE AIR INGRESS. THERE WAS NO PERMANENT HARM REPORTED, AND THE PATIENT STABILIZED AFTER IMMEDIATE CORRECTIVE INTERVENTIONS. NEVERTHELESS, PROBABLE HARMS, DUE TO AIR INGRESS INTO THE CLOSED ECMO CIRCUIT, MAY INVOLVE EMBOLIC COMPLICATIONS, IMPAIRED OXYGENATION, AND HEMODYNAMIC INSTABILITY. IN CONCLUSION, ALTHOUGH THE PRECISE ROOT CAUSE OF THE AIR INGRESS REMAINS UNIDENTIFIED, POTENTIAL CONTRIBUTING FACTORS MAY INCLUDE MICRO-LEAKS WITHIN THE CIRCUIT, INADVERTENT INTRODUCTION OF AIR THROUGH ACCESS POINTS, CHANGES IN VENOUS LINE PRESSURE, OR VIA A CENTRAL VENOUS CATHETER. NO EVIDENCE OF DEVICE MALFUNCTION OR USER ERROR WAS OBSERVED; HOWEVER, A THOROUGH INVESTIGATION IF THE PRODUCT WAS UNABLE TO BE PERFORMED, MAKING A POINTED DETERMINATION OF POSSIBLE ROOT CASES CHALLENGING. AS A NOTE, THE PATIENT¿S OUTCOME WAS REPORTED AS FAVORABLE AS A RESULT OF TIMELY RECOGNITION AND INTERVENTION." 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 2025-08-22. 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 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 "AIR INGRESS" COULD BE CONFIRMED DUE TO THE PROVIDED PICTURES OF THE CUSTOMER. 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 CHINA DURING TREATMENT. IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT WENT ON THE MACHINE AROUND 4 P.M. ONE HOUR LATER THE NURSE FOUND A SMALL NUMBER OF BUBBLES ABOVE THE OXYGENATOR MEMBRANE. THE MACHINE WAS SHUT DOWN AND THE BUBBLES WERE ELIMINATED. HOWEVER, AT AROUND 10 P.M. THE NURSE FOUND THAT THE BLOOD FLOW DECREASED AND A LARGE NUMBER OF SMALL BUBBLES APPEARED IN THE ENTIRE SET. THE PATIENT'S OXYGEN SATURATION CONTINUED TO DECREASE. THE HLS SET WAS REPLACED. AS OF 8 A.M. ON (B)(6) 2025 THE PATIENT SIGNS ARE CURRENTLY STABLE. NEW INFORMATION RECEIVED ON (B)(6) 2025 THAT DURING PRIMING PROCEDURE NO BUBBLES WERE SEEN AND THE ENTIRE HLS KIT USAGE PROCESS AND METHOD ARE IN ACCORDANCE WITH GETINGE INSTRUCTIONS. THE AFFECTED PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. AS THE HLS SET WAS REPLACED, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).
COMPLAINT ID#: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55479 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET | 3000436308 | 04058863078298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Life Threatening | UNKNOWN. |