TUBING SET
Report
- Report Number
- 3013876692-2025-00062
- Event Type
- Death
- Date Received
- July 30, 2025
- Date of Event
- July 25, 2025
- Report Date
- December 28, 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
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE SECOND USED HLS SET WHICH WAS CONNECTED WHEN THE PATIENT PASSED AWAY WITH LOT #3000423624 HAS BEEN SCRAPPED AND WAS NOT AVAILABLE FOR RETURN. THE FIRST USED HLS SET, WHICH HAD AIR IN CIRCUIT DURING PRIMING WITH LOT #3000432400 WAS AVAILABLE FOR INVESTIGATION AND HAS BEEN RETURNED. THIS AFFECTED HLS SET WAS INVESTIGATED IN THE GETINGE LABORATORY ON 2025-12-09. THE FAILURE COULD NOT BE CONFIRMED. DURING THE INSPECTION, NO ABNORMALITIES WERE DETECTED. THE REPORTED FAILURE "NOISE" COULD NOT BE REPRODUCED. A MEDICAL REVIEW WAS REQUESTED FROM GETINGE MEDICAL AFFAIRS. 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 PRE-MARKET 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. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT FOR TREATMENT DUE TO A CAR ACCIDENT. IT WAS REPORTED THAT THE HLS SET COULD NOT BE PRIMED DUE TO AIR BUBBLES IN THE CIRCUIT. THIS HLS SET WAS NEVER CONNECTED TO THE PATIENT. AS THE FIRST SET COULD NOT BE USED IMMEDIATELY, THERE WAS A DELAY IN TREATMENT. A SECOND HLS SET WAS USED AND HAS BEEN CONNECTED THE PATIENT TO PROCESS FURTHER. NO MALFUNCTION WAS REPORTED FOR THE SECOND USED HLS SET. THE PATIENT PASSED AWAY WHILE BEING CONNECTED TO THE SECOND HLS SET AFTER SEVERAL HOURS. EXCEPT FOR THE PATIENT'S AGE (58 YEARS), NO FURTHER PATIENT DATA REGARDING WEIGHT OR SEX WAS PROVIDED BY THE CUSTOMER. AS THE PATIENT PASSED AWAY A REPORT IS REQUIRED. THE SECOND USED HLS SET WHICH WAS CONNECTED WHEN THE PATIENT PASSED AWAY WITH LOT #3000432400 HAS BEEN SCRAPPED BY THE HOSPITAL AND WAS NOT AVAILABLE FOR INVESTIGATION AT THE MANUFACTURER SITE. THE FIRST USED HLS SET, WHICH HAD AIR IN CIRCUIT DURING PRIMING WITH LOT #3000436308 WAS AVAILABLE FOR INVESTIGATION AND HAS BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THIS AFFECTED HLS SET WAS INVESTIGATED IN THE GETINGE LABORATORY ON 2025-12-09 WITH THE FOLLOWING CONCLUSION: THE REPORTED FAILURE "AIR IN CIRCUIT" COULD NOT BE CONFIRMED. THE REPORTED FAILURE COULD NOT BE REPRODUCED, THEREFORE THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT CANNOT BE ATTRIBUTED TO A TECHNICAL MALFUNCTION OF THE HLS SET. HOWEVER, DURING THE INVESTIGATION IT WAS FOUND, THAT THE A SUBSTANTIAL MODIFICATION OF THE HLS SET WAS PERFORMED BY LENGTHENING THE TUBING SYSTEM. IT CANNOT BE EXCLUDED, THAT MOST PROBABLE THE DIFFERENT SYSTEM CONFIGURATION RESULTING FROM THE EXTENSION OF THE TUBING SYSTEM COULD HAVE LED TO A LONGER DE-AIRING TIME AND THUS CONTRIBUTED TO THE IMPRESSION OF A POSSIBLE MALFUNCTION. A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON (B)(6) 2025 WITH THE FOLLOWING CONCLUSION: "AN INCIDENT WAS REPORTED BY A CUSTOMER WHO WAS UNABLE TO PRIME AND DE-AIR AN HLS-SET 5.0. BASED ON THE INFORMATION AND VIDEO FOOTAGE PROVIDED, THE HLS-SET COULD NOT BE DE-AIRED, WHICH REQUIRED THE USE OF A SECOND HLS-SET 5.0 FOR PATIENT TREATMENT. THE LCE REPORT CLEARLY STATES THAT THERE WERE NO LEAKS OR OTHER TECHNICAL MALFUNCTIONS IN THE HLS-SET AND THAT THE PRIMING PROCEDURE COULD BE PERFORMED WITHOUT ANY REMARKS. THE MOST PROBABLE CAUSES OF ISSUES DURING THE PRIMING PROCESS OF THE HLS-SET IN QUESTION INCLUDE TECHNICAL DEFECTS SUCH AS LEAKAGE, CRACKS, OR DAMAGE TO THE TUBING, AS WELL AS USER SPECIFIC DEVIATIONS FROM THE INSTRUCTIONS FOR USE (IFU). ACCORDING TO THE INVESTIGATION REPORT CONDUCTED BY GETINGE, THE HLS-SET OPERATED WITHIN ITS SPECIFIED PARAMETERS. HOWEVER, A SUBSTANTIAL MODIFICATION OF THE DEVICE WAS PERFORMED. BY LENGTHENING THE TUBING SYSTEM, THE REQUIRED AMOUNT OF PRIMING SOLUTION AND THE TIME NEEDED FOR PROPER DEAIRING INCREASED TO AN INDETERMINATE LEVEL, MAKING ACCURATE FORECASTING OF THE PRIMING PROCEDURE IMPOSSIBLE. IT REMAINS UNCLEAR WHO LENGTHENED THE TUBING OF THE HLS-SET AND WHAT THE INTENTION BEHIND THIS ACTION WAS. THE QUESTIONNAIRE INCLUDED MULTIPLE QUESTIONS AIMED AT OBTAINING INFORMATION REGARDING THE PRIMING PROCEDURE. THEREFORE, THE CIRCUMSTANCES UNDER WHICH THIS MODIFICATION OCCURRED REMAIN UNKNOWN. FURTHER, IT IS UNCLEAR IF THE MODIFICATIONS MADE TO THE SET MAY HAVE CONTRIBUTED TO THE NONCONFORMANCE CITED BY THE CUSTOMER. LAST, IT IS UNCLEAR IF THERE WERE ANY DEVIATIONS FROM THE PRIMING PROTOCOL WHICH MAY HAVE CONTRIBUTED TO THE NONCONFORMANCE REPORTED BY THE CUSTOMER. BASED ON THE CLINICAL INDICATION FOR THE EXTRACORPOREAL CIRCUIT - MULTIPLE TRAUMA-RELATED INJURIES - IT REMAINS UNCLEAR WHAT ADDITIONAL MEASURES WERE UNDERTAKEN TO STABILIZE THE HIGHLY HEMODYNAMICALLY UNSTABLE PATIENT. PATIENTS SUSTAINING SEVERE TRAUMA ARE TYPICALLY AFFECTED BY BOTH EXTERNAL AND INTERNAL BLEEDING AND WOULD REQUIRE IMMEDIATE SURGICAL INTERVENTION TO CONTROL HEMORRHAGE. FAILURE TO DO SO COULD RESULT IN HYPOVOLEMIC SHOCK, ULTIMATELY LEADING TO CARDIAC ARREST DUE TO INSUFFICIENT BLOOD VOLUME TO MAINTAIN ADEQUATE BLOOD PRESSURE. A STUDY HIGHLIGHTED THAT THE LEADING CAUSE OF PREVENTABLE DEATHS IN TRAUMA PATIENTS IS UNCONTROLLED OR INADEQUATELY CONTROLLED HEMORRHAGE. AS NO INFORMATION WAS PROVIDED BY THE CUSTOMER, IT IS NOT POSSIBLE TO DETERMINE WHETHER THE SUSTAINED INJURIES CAUSED SIGNIFICANT HEMORRHAGE OR WHETHER THEY WOULD HAVE BEEN POTENTIALLY SURVIVABLE. A RECENT STUDY DISCUSSED THE USE OF ECMO IN TRAUMA PATIENTS, CONCLUDING THAT ECMO HAS BEEN INCREASINGLY UTILIZED AS A LIFESAVING INTERVENTION IN CASES OF SEVERE TRAUMA, AND ITS FEASIBILITY AND POTENTIAL BENEFITS ARE BECOMING WIDELY RECOGNIZED. HOWEVER, THE SAFETY AND EFFECTIVENESS OF ECMO IN TRAUMA REQUIRE FURTHER INVESTIGATION, AS SEVERAL ISSUES REMAIN CONTROVERSIAL, INCLUDING THE ROLE OF VA-ECMO, OPTIMAL TIMING FOR ECMO INITIATION, AND APPROPRIATE ANTICOAGULATION STRATEGIES. THESE CHALLENGES MUST BE ADDRESSED IN FUTURE STUDIES. HOWEVER, AS NO SPECIFIC CLINICAL DATA WERE AVAILABLE FROM THE CUSTOMER, THESE ASSUMPTIONS CANNOT BE VERIFIED. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT¿S CONDITION DETERIORATED PROGRESSIVELY DURING THE PERIOD OF EXTRACORPOREAL SUPPORT, LEADING THE PHYSICIANS TO DISCONTINUE ECMO THERAPY AFTER SEVERAL HOURS OF TREATMENT. THE CUSTOMER CONFIRMED THAT THE PATIENT EXPIRED SHORTLY AFTER ECMO WAS TERMINATED; HOWEVER. IN CONCLUSION, A PRODUCT MALFUNCTION OF THE HLS-SET - PARTICULARLY ISSUES SUCH AS LEAKAGE OR INABILITY TO DE-AIR - CAN BE RULED OUT SECONDARY TO THE INSPECTION PERFORMED BY GETINGE." IN THE INSTRUCTION OF USE OF THE HLS SET (CHAPTER "BASIC SAFETY INSTRUCTIONS") IT IS STATED THAT "MODIFICATIONS TO THE DEVICE CAN RESULT IN SERIOUS INJURIES TO OR DEATH OF THE PATIENT. DO NOT MODIFY THE DEVICE". THE CUSTOMER WILL BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER "BASIC SAFETY INSTRUCTIONS" WHERE IT IS STATED TO NOT MODIFY THE SYSTEM. ACCORDING TO THE INSTRUCTION OF USE OF THE HLS SET (CHAPTER "SAFETY INSTRUCTIONS FOR THE OXYGENATOR") IT IS STATED THAT THE DE-AIRING MEMBRANE MUST BE OPEN THROUGHOUT PRIMING TO ENSURE SAFE DE-AIRING OF THE OXYGENATOR AND TO ENSURE THAT THE DE-AIRING MEMBRANE OF THE OXYGENATOR IS CLOSED WITH THE YELLOW PROTECTIVE CAP DURING OPERATION. 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. IN CHAPTER "PRIMING THE SYSTEM" IT IS MENTIONED THAT PRE-PRIMING CAN CAUSE AIR BUBBLES TO FORM IN THE SYSTEM. REFERRING TO THE CHAPTER "START PERFUSION" THE CUSTOMER SHOULD ENSURE THAT THE TUBE SYSTEM HAS BEEN COMPLETELY DE-AIRED BEFORE STARTING THE PERFUSION. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON (B)(6) 2025. ACCORDING TO THE FINAL TEST RESULTS, BOTH PRODUCTS 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 REGARDS TO THE REPORTED PRODUCT AND FAILURE. BASED ON THE RESULTS, THE REPORTED FAILURE "AIR IN CIRCUIT" COULD NEITHER BE CONFIRMED NOR LINKED TO A DEVICE DEFECT AND COULD NOT BE RELATED TO THE PATIENT'S DEATH. THIS COMPLAINT WAS FOUND AS A SINGLE EVENT IN THE DATABASE OF CUSTOMER COMPLAINTS FOR THE INDICATED TIMEFRAME. 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. 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 701069076.
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. 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 701069076.
COMPLAINT ID# (B)(4).
COMPLAINT ID #: (B)(4).
THE EVENT OCCURRED IN CHINA. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT FOR TREATMENT DUE TO A CAR ACCIDENT. IT WAS REPORTED THAT THE HLS SET COULD NOT BE PRIMED DUE TO AIR BUBBLES IN THE OXYGENATOR. THIS HLS SET WAS NEVER CONNECTED TO THE PATIENT. AS THE FIRST SET COULD NOT BE USED IMMEDIATELY, THERE WAS A DELAY IN TREATMENT. A SECOND HLS SET WAS USED AND HAS BEEN CONNECTED THE PATIENT TO PROCESS FURTHER. THE PATIENT PASSED AWAY WHILE BEING CONNECTED TO THE SECOND HLS SET AFTER SEVERAL HOURS. AS THE PATIENT PASSED AWAY A REPORT IS REQUIRED. COMPLAINT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 514734 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET | 3000432400 | 04058863078298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Unknown | Death | UNKNOWN. |