TUBING SET
Report
- Report Number
- 8010762-2025-0000350
- Event Type
- Malfunction
- Date Received
- August 13, 2025
- Date of Event
- August 5, 2025
- Report Date
- December 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
- EZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS EVENT OCCURRED ON THE CZECHIA 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 INFORMATION WAS RECEIVED, THAT THE INCIDENT WITH THE HLS SET DID NOT HAVE ANY IMPACT ON THE PATIENT. THE PATIENT WAS SUCCESSFULLY WEANED OFF FROM ECMO. THE PATIENT WAS CONNECTED TO ECMO DUE TO FOLLOWING CLINICAL CONDITION BEFORE THE INCIDENT WITH THE HLS SET: ACUTE MYOCARDIAL INFARCTION AND CARDIOPULMONARY RESUSCITATION. THE HLS SET WAS FILLED ON THE SAME DAY AS IT WAS CONNECTED TO THE PATIENT ON (B)(6) 2025. THERE WAS NO MALFUNCTION AND NO NOISE NOTICED DURING FILLING. THE AFFECTED HLS SET WAS INVESTIGATED IN THE GETINGE LABORATORY ON 2025-10-24: THE REPORTED FAILURE WAS CONFIRMED DURING THE INVESTIGATION. DURING THE VISUAL INSPECTION, A CLOT-STRUCTURED FOREIGN OBJECT WAS DETECTED IN THE AREA OF THE ROTOR. INVESTIGATION IS ONGOING. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE CZECHIA 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 (B)(6). IT WAS REPORTED WHILE PERFORMING A ROUTINE INSPECTION ON DAY FOUR OF THE PATIENT TREATMENT, A CLICKING NOISE WAS HEARD COMING FROM THE HLS SET OXYGENATOR. THE SOUND OF THE CLICKING RESPONDED TO THE SPEED, WHEN THE SPEED WAS INCREASED, THE CLICKING BECAME LOUDER. THE HLS SET WAS PLACED ON ANOTHER CARDIOHELP DEVICE, BUT THE NOISE PERSISTED. A REPLACEMENT WAS CARRIED OUT WITH A DEVICE FROM FRESENIUS. THE INCIDENT WITH THE HLS SET DID NOT HAVE ANY IMPACT ON THE PATIENT. THE PATIENT WAS SUCCESSFULLY WEANED OFF FROM ECMO. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE PATIENT WAS CONNECTED TO ECMO DUE TO FOLLOWING CLINICAL CONDITION BEFORE BEING CONNECTED WITH THE HLS-SET: ACUTE MYOCARDIAL INFARCTION AND CARDIOPULMONARY RESUSCITATION. THE HLS SET WAS FILLED ON THE SAME DAY AS IT WAS CONNECTED TO THE PATIENT ON (B)(6) 2025. THERE WAS NO MALFUNCTION AND NO NOISE NOTICED DURING FILLING. AS THE HLS SET WAS REPLACED DURING THE PATIENTS TREATMENT, A REPORT IS REQUIRED. THE AFFECTED HLS SET WAS INVESTIGATED IN THE GETINGE LABORATORY ON 2025-10-24 WITH THE FOLLOWING CONCLUSION: "THE REPORTED FAILURE WAS CONFIRMED DURING THE INVESTIGATION. DURING THE VISUAL INSPECTION, A CLOT-STRUCTURED FOREIGN OBJECT WAS DETECTED IN THE AREA OF THE ROTOR. HOWEVER, AFTER CLEANING THE PRODUCT, NO NOISE WAS DETECTABLE. THE FLUSHED-OUT FOREIGN OBJECT WAS IDENTIFIED AS THE CAUSE OF THE NOISE. THE FOLLOWING FUNCTIONAL TESTS REVEALED NO FURTHER ABNORMALITIES. IT CAN BE ASSUMED THAT THE FOREIGN OBJECT DETECTED BECAME DETACHED FROM THE PATIENT DURING ECMO THERAPY AND ENTERED THE EXTRACORPOREAL CIRCUIT. DUE TO ITS DIAMETER, THE FOREIGN OBJECT COULD NOT BE TRANSPORTED FURTHER TOWARDS THE OXYGENATOR AND REMAINED IN THE PUMP MODULE, WEDGED BETWEEN THE ROTOR AND THE UPPER PART OF THE PUMP HOUSING. THIS LED TO THE OBSERVED NOISE AND THE DOCUMENTED GRINDING MARKS." THE REPORTED EVENT WAS EVALUATED BY GETINGE MEDICAL AFFAIRS ON 2025 WITH THE FOLLOWING CONCLUSION ON 2025-12-05: "AN INCIDENT WAS REPORTED INVOLVING ATYPICAL ACOUSTIC EMISSIONS ORIGINATING FROM A USED HLS SET 7.0. BASED ON THE INFORMATION AND VIDEO FOOTAGE PROVIDED BY THE CUSTOMER, THE HLS-SET ITSELF WAS IDENTIFIED AS THE SOURCE OF THE CLICKING SOUND. THE MOST PROBABLE CAUSES FOR THE REPORTED NOISE WERE CONSIDERED TO BE EITHER AN IMBALANCE OF THE HLS-SET PUMP ROTOR OR THE PRESENCE OF A FOREIGN BODY IMPEDING ITS FREE ROTATION. ACCORDING TO THE INVESTIGATION REPORT CONDUCTED BY GETINGE, THE PUMP OPERATED WITHIN ITS SPECIFIED PARAMETERS. HOWEVER, A SUBSTANTIAL ACCUMULATION OF BIOLOGICAL MATERIAL WAS DETECTED WITHIN THE ROTOR HOUSING OF THE HLS-SET PUMP. THE UNDESIRED NOISE WAS FIRST OBSERVED AFTER FOUR DAYS OF USE, SUGGESTING THAT THE BIOLOGICAL MATERIAL GRADUALLY ACCUMULATED OVER TIME AND SUBSEQUENTLY DETACHED FROM ITS UNKNOWN SITE OF ORIGIN. BECAUSE THE MASS WAS TOO LARGE TO PASS FREELY THROUGH THE PUMP, IT LIKELY INTERFERED WITH THE ROTOR MOVEMENT, RESULTING IN MECHANICAL IMBALANCE. THIS IMBALANCE MANIFESTED AS THE SOUND REPORTED BY THE CUSTOMER AND WAS CORROBORATED BY THE PRESENCE OF STRESS MARKS OBSERVED DURING THE INVESTIGATION. AS NO HISTOLOGICAL EXAMINATION OF THE BIOLOGICAL MATERIAL WAS PERFORMED, THE PRECISE COMPOSITION AND ORIGIN OF THE CONGLOMERATE REMAIN UNDETERMINED. IT IS PLAUSIBLE THAT THE OBSERVED STRUCTURE REPRESENTED A THROMBOTIC FORMATION STABILIZED BY FIBRINOGEN AND OTHER TISSUE COMPONENTS. THE ORIGIN OF THE THROMBUS REMAINS UNCERTAIN, PARTICULARLY WHETHER IT WAS ASSOCIATED WITH THE ANTICOAGULATION REGIMEN AND/OR AN UNDERLYING COAGULOPATHY IN THE PATIENT. NEVERTHELESS, THE THROMBUS MOST LIKELY ORIGINATED FROM THE PATIENT (E.G., DEEP VEIN THROMBOSIS, RIGHT ATRIAL THROMBUS) AND WAS SUBSEQUENTLY ASPIRATED INTO THE PUMP OF THE HLS SET. BASED ON THE CLINICAL INDICATION FOR THE EXTRACORPOREAL CIRCUIT - ACUTE MYOCARDIAL INFARCTION - IT IS REASONABLE TO ASSUME THAT CORONARY STENTS WERE IMPLANTED, AND THAT DUAL ANTIPLATELET THERAPY WAS INITIATED. HOWEVER, AS NO SPECIFIC CLINICAL DATA WERE AVAILABLE FROM THE CUSTOMER, THIS ASSUMPTION CANNOT BE VERIFIED. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE PATIENT'S CONDITION IMPROVED STEADILY DURING THE PERIOD OF EXTRACORPOREAL SUPPORT. THE CIRCUIT CHANGE TO A COMPETITOR'S DEVICE, WHICH WAS PERFORMED DUE TO THE REPORTED CLICKING SOUND, DID NOT IMPAIR THE PATIENT'S CLINICAL PROGRESS. THE PATIENT WAS SUCCESSFULLY WEANED FROM ECMO SUPPORT, AND THE SYSTEM WAS EXPLANTED ON (B)(6) 2025 - 12 DAYS AFTER INITIATION. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS SUCCESSFULLY WEANED FROM ECMO. IN CONCLUSION, A PRODUCT MALFUNCTION OF THE HLS-SET, ESPECIALLY THE PUMP, IN QUESTION COULD BE RULED OUT, BUT AN IMPAIRMENT OF THE PUMP, DUE TO A FOREIGN BODY IN THE AREA OF THE PUMP INLET, IS PROPOSED AS A HIGHLY POSSIBLE ROOT CAUSE. THE ORIGIN OF THIS TISSUE-FORMATION STAYS UNCLEAR." ACCORDING TO THE INSTRUCTIONS OF USE OF THE HLS SET (CHAPTER SAFETY INSTRUCTIONS FOR CENTRIFUGAL PUMP) IT IS STATED THAT TO LISTEN FOR SCRATCHING NOISES WHEN PRIMING THE SYSTEM AND TO REPLACE THE HLS SET ADVANCED IF THERE ARE SCRATCHING NOISES. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2025-10-29. ACCORDING TO THE FINAL TEST RESULTS, THE MODULE WITH LOT# 3000445884 AND UDI# (B)(4) PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY. 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 PRODUCT AND FAILURE. BASED ON THE RESULTS, THE REPORTED FAILURE "NOISE" COULD BE CONFIRMED BUT WAS NOT RELATED TO A DEVICE MALFUNCTION. THIS COMPLAINT WAS FOUND IN THE DATABASE OF CUSTOMER COMPLAINTS FOR THE PRODUCT HLS SET WITH ARTICLE #701069073 AS A SINGLE EVENT (TIMEFRAME FROM 2024-08-10 TILL 2025-08-10). 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. NOTE: THIS EVENT OCCURRED ON THE (B)(6). 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 CZECHIA. IT WAS REPORTED THAT DURING PATIENT TREATMENT A CLICKING NOISE WAS COMING FROM THE HLS SET OXYGENATOR. THE SOUND OF THE CLICKING RESPONDED TO THE SPEED, WHEN THE SPEED WAS INCREASED, THE CLICKING BECAME LOUDER. THE HLS SET WAS PLACED ON ANOTHER CARDIOHELP DEVICE, BUT THE NOISE PERSISTED. A REPLACEMENT WAS CARRIED OUT WITH A DEVICE FROM XENIOS FRESENIUS. THE PATIENT HAD A HEART ATTACK, AFTER RESUSCITATION. AS THE PATIENT HAD TO BE RESUSCITATED AND SUFFERED A HEART ATTACK, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).
COMPLAINT ID# (B)(4) - THE INFORMATION WAS RECEIVED, THAT THE INCIDENT WITH THE HLS SET DID NOT HAVE ANY IMPACT ON THE PATIENT. THE PATIENT WAS SUCCESSFULLY WEANED OFF FROM ECMO. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE PATIENT WAS CONNECTED TO ECMO DUE TO FOLLOWING CLINICAL CONDITION BEFORE THE INCIDENT WITH THE HLS SET: ACUTE MYOCARDIAL INFARCTION AND CARDIOPULMONARY RESUSCITATION. AS THE HLS SET WAS REPLACED DURING THE PATIENTS TREATMENT, A REPORT IS REQUIRED.
COMPLAINT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65377 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET | 3000451267 | 04058863005744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Life Threatening| R |