TUBING SET
Report
- Report Number
- 3013876692-2025-00105
- Event Type
- Death
- Date Received
- December 19, 2025
- Date of Event
- December 14, 2025
- Report Date
- March 6, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- UDI-DI
- 04058863005744
- 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
NEW INFORMATION WAS RECEIVED ON (B)(6) 2026 THAT THE ECMO WAS REQUIRED DUE TO THE PATIENT HAVING ARDS. ON (B)(6) 2026 THE CONFIRMATION WAS RECEIVED BY THE GETINGE SERVICE AND SALES THAT THREE GFE WERE SENT TO THE CUSTOMER WITH NO RESPONSE. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THE LOT NUMBER OF THE AFFECTED SET WAS NOT PROVIDED. THEREFORE, IT IS NOT POSSIBLE TO IDENTIFY THE SET LOT NUMBER OF THE DEVICE IN QUESTION AND THEREFORE ITS UDI NUMBER.
ADDITIONAL INFORMATION FROM THE FRENCH AUTHORITY WAS RECEIVED ON 2026-02-24 THAT THE MODULE LOT IS: 3000482950. THEREFORE, THE ARTICLE OF THE SET IS: 701069073, MANUFACTURED ON 2025-06-02. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2026-03-02. 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. NOTE: THIS EVENT OCCURRED ON THE FRENCH 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 FRANCE DURING TREATMENT. IT WAS REPORTED THAT A RAPID MEMBRANE (HLS SET) THROMBOSIS (CLOTTING) OCCURRED ON A MODULE CONNECTED TO A PATIENT ON VV ECMO. FOLLOWING PATIENT DATA WAS SHARED: MALE, 25 YEARS. THE PATIENT UNDERWENT VV ECMO FOR ARDS (ACUTE RESPIRATORY DISTRESS SYNDROME). THE FIRST HLS SET WAS REPLACED ON TREATMENT DAY 14 OF ECMO AND THE SECOND HLS SET WAS REPLACED ON TREATMENT DAY 22. THE PATIENT WAS NOT RECEIVING ANY ANTICOAGULANTS DUE TO ONGOING MUCOSAL BLEEDING, INCLUDING PULMONARY BLEEDING. DUE TO HYPOVOLEMIA RELATED TO THE BLEEDING THE PATIENT SUFFERED A CARDIAC ARREST. RESUSCITATION WAS PERFORMED FOR 20 MINUTES. DURING THE FIRST 15 MINUTES THE PATIENTS SAO2 WAS 100 PERCENTAGES AND PO2 WAS 200 MMHG WITH AN ECMO FLOW RATE OF 5L. A BLOOD GAS ANALYSIS WAS PERFORMED BY THE CUSTOMER DUE TO THE DESATURATION AND HYPOXIA OF THE PATIENT. THE BLOOD GAS ANALYSIS REVEALED A PO2 OF 70 MMHG. THE CUSTOMER CHECKED THE ECMO OXYGEN CONNECTIONS AND NO CLOT/THROMBUS WAS VISUALIZED WITHIN THE HLS SET. AFTER THE BLOOD GAS ANALYSIS AN INCREASE IN DELTA PRESSURE APPEARED, WHICH CONFIRMED THE CLOTTING ACCORDING TO THE CUSTOMER. THE PATIENT PASSED AWAY. THE PATIENT PASSED AWAY. THE HLS SET WAS REPLACED TWICE AND THE PATIENT SUFFERED BAD OXYGENATION/CLOTTING, THEREFORE A REPORT IS REQUIRED. NEW INFORMATION WAS RECEIVED ON 2026-01-12 THAT THE ECMO WAS REQUIRED DUE TO THE PATIENT HAVING ARDS. ON 2026-01-28, THE CONFIRMATION WAS RECEIVED BY THE GETINGE SERVICE AND SALES THAT THREE GFE WERE SENT TO THE CUSTOMER WITH NO RESPONSE. THEREFORE, NO TECHNICAL INVESTIGATION OF THE PRODUCT COULD BE PERFORMED. HOWEVER, A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON 2026-02-04 WITH FOLLOWING CONCLUSION: "THE INFORMATION RECEIVED FROM THE CUSTOMER DESCRIBES A PATIENT ON VV-ECMO SUPPORT FOR ARDS WHO EXPERIENCED PRONOUNCED MUCOSAL AND PULMONARY BLEEDING. ACCORDING TO THE COMPLAINT REPORT AND CORRESPONDENCE, SYSTEMIC ANTICOAGULATION WAS NOT ADMINISTERED DUE TO THE EXTENT OF THE BLEEDING. THE CUSTOMER ALSO REPORTED THAT THE ECMO MEMBRANE WAS REPLACED ON ECMO SUPPORT DAY 14 AND AGAIN ON DAY 22. ON THE DAY OF THE REPORTED EVENT, INITIALLY STABLE OXYGENATION PARAMETERS WERE FOLLOWED BY A SUDDEN DECLINE IN POST-OXYGENATOR GAS TRANSFER, TOGETHER WITH AN INCREASE IN THE PRESSURE DROP ACROSS THE OXYGENATOR. THE CUSTOMER STATED THAT NO ABNORMALITIES WERE IDENTIFIED IN THE OXYGEN SUPPLY CONNECTIONS AND THAT NO VISIBLE THROMBUS WAS NOTED ON THE MEMBRANE SURFACE DURING EXTERNAL INSPECTION. NO FURTHER CLINICAL INFORMATION, NO PERFUSION DOCUMENTATION, AND NO DEVICE-RELATED DATA WERE SUBMITTED DESPITE REPEATED REQUESTS. THE HLS SETS USED IN THE CASE WERE NOT RETURNED, PREVENTING ANY TECHNICAL EXAMINATION OR CONFIRMATION OF THE OBSERVATIONS OR IDENTIFICATION OF POSSIBLE ROOT CAUSES. BECAUSE NO LOT NUMBERS, PERFUSION LOGS, OR DEVICE SAMPLES WERE MADE AVAILABLE, A DEFINITIVE OR PROPOSED ROOT CAUSE CANNOT BE DETERMINED OR ADVANCED. THE INFORMATION PROVIDED DOES NOT ALLOW VERIFICATION OF A DEVICE MALFUNCTION, NOR DOES IT ALLOW CONFIRMATION OR EXCLUSION OF POSSIBLE ASSOCIATIONS BETWEEN THE REPORTED EVENT AND PRODUCT PERFORMANCE. NO INFORMATION SUGGESTING A USE-RELATED CONTRIBUTION WAS REPORTED WHICH CANNOT BE EVALUATED FURTHER WITHOUT OPERATIONAL DATA. THE CLINICAL BACKGROUND DESCRIBED BY THE SITE-CHARACTERIZED BY SEVERE BLEEDING, ABSENCE OF SYSTEMIC ANTICOAGULATION AS REPORTED BY THE CUSTOMER, REPEATED MEMBRANE EXCHANGES, AND CARDIOVASCULAR INSTABILITY - CANNOT BE FURTHER QUALIFIED IN TERMS OF ITS INFLUENCE ON THE SEQUENCE OF EVENTS. THE CUSTOMER ADDITIONALLY ASKED WHETHER MEMBRANE THROMBOSIS CAN OCCUR WITHOUT A VISIBLE THROMBUS ON ¿LAMP INSPECTION¿ (VISUAL INSPECTION) AND WHETHER A SUDDEN LOSS OF OXYGENATION CAN OCCUR RAPIDLY. ACCORDING TO THE ELSO GUIDELINES FOR CARDIOPULMONARY EXTRACORPOREAL LIFE SUPPORT, THROMBOSIS WITHIN THE FIBER BUNDLE MAY NOT BE EXTERNALLY VISIBLE, AND ACUTE REDUCTIONS IN GAS TRANSFER CAN OCCUR ABRUPTLY DURING ECMO SUPPORT. THESE STATEMENTS REFLECT GENERAL ECMO PRINCIPLES AND DO NOT PERMIT CONCLUSIONS SPECIFIC TO THIS CASE, AS THE DEVICE WAS NOT RETURNED, AND NO FURTHER CLINICAL DETAILS WERE PROVIDED. THE INSTRUCTIONS FOR USE (IFU) THE HLS SET STATES THE FOLLOWING REGARDING CONTRAINDICATIONS, WARNINGS, AND CAUTIONS. - CHAPTER "CONTRAINDICATION" THE BENEFITS OF EXTRACORPOREAL CIRCULATORY AND/OR PULMONARY SUPPORT HAVE TO BE WEIGHED AGAINST THE RISKS OF SYSTEMIC ANTICOAGULATION TREATMENT. IN THE CASE OF PATIENTS WHO SUFFER FROM SEVERE BLEEDING OR SERIOUS COAGULATION DISORDERS, EXTRACORPOREAL CIRCULATORY SUPPORT MAY REPRESENT A CONTRAINDICATION. HEMODILUTION CAUSED BY THE PRIMING LIQUID IN THE SYSTEM MUST ALSO BE TAKEN INTO ACCOUNT. THE CHOICE OF PRIMING LIQUID AND DRUGS USED SHOULD ALSO TAKE INTO ACCOUNT POSSIBLE ALLERGIC REACTIONS OF PATIENTS. CONTRAINDICATIONS: THE TARGETED USE FOR AN UNLIMITED PERIOD OF TIME FOR CARDIAC SUPPORT ("DESTINATION THERAPY"). DEPENDING ON THE CANNULATION OPTIONS AND AREA OF PERFUSION, VASCULAR DISSECTIONS MAY REPRESENT A CONTRAINDICATION. - SEVERE AORTIC VALVE INSUFFICIENCY IN THE CASE OF VENO-ARTERIAL CIRCULATION. THE DEVICE WITH BIOLINE COATING (HEPARIN-ALBUMIN COATING) MUST NOT BE USED WITH: PATIENTS WITH KNOWN HYPERSENSITIVITY TO HEPARIN (HEPARIN ALLERGY). PATIENTS CURRENTLY SUFFERING FROM, OR WITH A HISTORY OF, TYPE II ANTIBODY-RELATED HEPARIN-INDUCED THROMBOCYTOPENIA (HIT). CHAPTER "SAFETY INSTRUCTIONS FOR THE EXTRACORPOREAL CIRCULATION". IMPLEMENTING AN EXTRACORPOREAL CIRCULATION CAN CAUSE THE ASSOCIATED SIDE EFFECTS IN THE PATIENT, SUCH AS INFECTIONS, HEMOLYSIS, EMBOLISMS, POST-PERFUSION SYNDROME AND ORGAN DAMAGE. MONITOR THE PATIENT REGULARLY FOR POSSIBLE SIDE EFFECTS. NO ANTICOAGULATION OR INSUFFICIENT ANTICOAGULATION CAUSES OCCLUSION OF THE EXTRACORPOREAL CIRCULATION AND THE PATIENT CIRCUIT. THIS CAN LEAD TO INADEQUATE PATIENT SUPPORT, HEMOLYSIS OR THROMBUS FORMATION IN THE PATIENT. WEIGH THE BENEFITS OF EXTRACORPOREAL CIRCULATION AGAINST THE RISK OF SYSTEMIC ANTICOAGULATION. USE ANTICOAGULANTS, E.G. HEPARIN OR ARGATROBAN. CHECK THE EFFECT OF ANTICOAGULANTS AT REGULAR INTERVALS BY MEASURING THE ACT (ACTIVATED CLOTTING TIME). ENSURE THAT THE ACT VALUE DOES NOT FALL BELOW THE VALUE WHICH IS APPROPRIATE FOR THE APPLICATION. CHECK THE COAGULATION STATUS OF THE PATIENT'S BLOOD REGULARLY. THE PROTOCOL FOR COAGULATION MANAGEMENT IS THE RESPONSIBILITY OF THE USER IN CHARGE. THE PARTIAL THROMBOPLASTIN TIME (PTT) SHOULD BE IN THE RANGE FROM 60 TO 90 SECONDS. AN ANTITHROMBIN III (AT III) VALUE IN THE NORMAL RANGE IS REQUIRED FOR RELIABLE ANTICOAGULANT THERAPY WITH HEPARIN. AS THE IFU STATES:¿ THE BENEFITS OF EXTRACORPOREAL CIRCULATORY AND/OR PULMONARY SUPPORT HAVE TO BE WEIGHED AGAINST THE RISKS OF SYSTEMIC ANTICOAGULATION TREATMENT. IN THE CASE OF PATIENTS WHO SUFFER FROM SEVERE BLEEDING OR SERIOUS COAGULATION DISORDERS, EXTRACORPOREAL CIRCULATORY SUPPORT MAY REPRESENT A CONTRAINDICATION.¿ DECISIONS REGARDING ANTICOAGULATION ARE MADE BY THE TREATING MEDICAL TEAM BASED ON THE INDIVIDUAL CLINICAL CIRCUMSTANCES. AS OUTLINED IN THE IFU, THE PATIENT¿S UNDERLYING CONDITION AND PERIODS WITHOUT SYSTEMIC ANTICOAGULATION MAY BE ASSOCIATED WITH AN INCREASED RISK OF CIRCUIT-RELATED COMPLICATIONS. CHAPTER 5.2 OF THE IFU NOTES THAT ABSENT OR INSUFFICIENT ANTICOAGULATION CAN CONTRIBUTE TO OCCLUSION WITHIN THE EXTRACORPOREAL CIRCUIT, WHICH MAY RESULT IN REDUCED SUPPORT, HEMOLYSIS, OR THROMBUS FORMATION. IN ADDITION, AN UNDIAGNOSED PROTHROMBOTIC CONDITION, SUCH AS HEPARIN-INDUCED THROMBOCYTOPENIA (HIT), CANNOT BE EXCLUDED BASED ON THE INFORMATION AVAILABLE. IN PATIENTS RECEIVING ECMO SUPPORT, HIT MAY PRESENT ATYPICALLY AND CAN BE ASSOCIATED WITH BOTH BLEEDING MANIFESTATIONS AND THROMBOTIC COMPLICATIONS, INCLUDING CIRCUIT-RELATED THROMBOSIS. IN THE ABSENCE OF DETAILED ANTICOAGULATION HISTORY, PLATELET COUNT TRENDS, HIT ANTIBODY TESTING, OR FUNCTIONAL ASSAY RESULTS, IT IS NOT POSSIBLE TO ASSESS WHETHER HIT MAY HAVE CONTRIBUTED TO A PROTHROMBOTIC STATE OR TO THE OBSERVED CHANGES IN OXYGENATOR PERFORMANCE. THIS CONSIDERATION IS PROVIDED FOR COMPLETENESS, AS PATIENT-RELATED PROCOAGULANT CONDITIONS MAY INFLUENCE EXTRACORPOREAL CIRCUIT FUNCTION INDEPENDENTLY OF DEVICE PERFORMANCE. DUE TO THE ABSENCE OF DEVICE RETURN AND MISSING ESSENTIAL CLINICAL AND DEVICE INFORMATION, AN ASSOCIATION BETWEEN THE REPORTED EVENT AND THE PRODUCT CANNOT BE DETERMINED. HOWEVER, THE PRESENCE OF CLOT FORMATION OBSTRUCTING SIGNIFICANT PORTIONS OF THE OXYGENATORS SURFACE, EVEN IN ABSENCE OF VISIBLE THROMBUS, MAY REPRESENT THE MOST LIKELY EXPLANATION OF THE REPORTED INCREASE IN TRANS-OXYGENATOR PRESSURE DROP IN COEXISTENCE WITH REDUCTION IN GAS EXCHANGE. THE ACCOUNT FROM THE CUSTOMER APPEARS TO CORROBORATE THE PRESENCE OF THROMBUS IN THE MEMBRANE OF THE HLS MODULE. A REDUCTION IN PAO2 COUPLED WITH AN INCREASE IN DELTA PRESSURE ACROSS THE MEMBRANE SUGGEST A REDUCTION IN TOTAL MEMBRANE AREA. A PRESENCE OF CONDENSATION MAY HAVE EXACERBATED A REDUCTION IN GAS TRANSFER. DESPITE ACTIVE BLEEDING AS REPORTED, A LACK OF ANTICOAGULATION MAY HAVE ACCELERATED THE GENERATION OF THROMBUS IN THE HLS MODULE NOTWITHSTANDING SIGNIFICANT/PERTINENT COAGULOPATHIES. LAST, WHILE THE REPORTED REDUCTION OF PAO2 (DUE TO A REDUCTION IN MEMBRANE AREA) MAY HAVE CONTRIBUTED TO THE OUTCOME OF THE PATIENT, IT IS CHALLENGING TO ASSIGN A CAUSAL ASSOCIATION OF THE PATIENT OUTCOME SOLELY TO THAT EVENT, I.E., INDEPENDENT OF OTHER PROMINENT COMORBIDITIES. FURTHER, AS MENTIONED PREVIOUSLY, WITHOUT A THOROUGH INVESTIGATION OF THE PRODUCT, A DEFINITIVE, PROPOSED, OR POSSIBLE ROOT CAUSE(S) MAY NOT BE APPROACHED." NO DEVICE HISTORY REVIEW COULD BE CONFIRMED, AS THE AFFECTED LOT# OF THE PRODUCT WAS NOT AVAILABLE. AS WELL AS THE REVIEW OF SCRAP, REWORK, ENHANCEMENTS AND DESIGN CHANGES. 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 "CLOTTING AND BAD OXYGENATION" COULD NOT BE CONFIRMED. 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.
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THE LOT NUMBER OF THE AFFECTED SET WAS NOT PROVIDED. THEREFORE, IT IS NOT POSSIBLE TO IDENTIFY THE SET LOT NUMBER OF THE DEVICE IN QUESTION AND THEREFORE ITS UDI NUMBER.
COMPLAINT ID# (B)(4).
COMPLAINT ID (B)(4).
COMPLAINT ID: (B)(4).
THE EVENT OCCURRED IN FRANCE DURING TREATMENT. IT WAS REPORTED THAT A RAPID MEMBRANE (HLS SET) THROMBOSIS (CLOTTING) OCCURRED ON A MODULE CONNECTED TO A PATIENT ON VV ECMO. FOLLOWING PATIENT DATA WAS SHARED: MALE, 25 YEARS. THE PATIENT UNDERWENT VV ECMO FOR ARDS (ACUTE RESPIRATORY DISTRESS SYNDROME). THE FIRST HLS SET WAS REPLACED ON TREATMENT DAY 14 OF ECMO AND THE SECOND HLS SET WAS REPLACED ON TREATMENT DAY 22. THE PATIENT WAS NOT RECEIVING ANY ANTICOAGULANTS DUE TO ONGOING MUCOSAL BLEEDING, INCLUDING PULMONARY BLEEDING. DUE TO HYPOVOLEMIA RELATED TO THE BLEEDING THE PATIENT SUFFERED A CARDIAC ARREST. RESUSCITATION WAS PERFORMED FOR 20 MINUTES. DURING THE FIRST 15 MINUTES THE PATIENTS SAO2 WAS 100% AND PO2 WAS 200 MMHG WITH AN ECMO FLOW RATE OF 5L. A BLOOD GAS ANALYSIS WAS PERFORMED BY THE CUSTOMER DUE TO THE DESATURATION AND HYPOXIA OF THE PATIENT. THE BLOOD GAS ANALYSIS REVEALED A PO2 OF 70 MMHG. THE CUSTOMER CHECKED THE ECMO OXYGEN CONNECTIONS AND NO CLOT/THROMBUS WAS VISUALIZED WITHIN THE HLS SET. AFTER THE BLOOD GAS ANALYSIS AN INCREASE IN DELTA PRESSURE APPEARED, WHICH CONFIRMED THE CLOTTING ACCORDING TO THE CUSTOMER. THE PATIENT PASSED AWAY. THE HLS SET WAS REPLACED TWICE AND THE PATIENT SUFFERED BAD OXYGENATION/CLOTTING, THEREFORE A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114927 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET | 3000482351 | 04058863005744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Male | Death |