MAUDE Adverse Event Report: EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	US5062
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A.Patient information was not provided by the customer.Section d4: the primary udi number in d4 is reflective of all currently available information no further info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that limited information was available other than the story that the amg oxygenator clotted within 30 minutes of initiation resulting in low flows despite max centrimag's rpm's and high delta p's.The perfusionist recognized a possible oxygenator thrombus and elected to change out the oxygenator.
Event or Problem Description
It was said the blood flow was 2.5 lpm, the rpm was 4500, and the sweep was 3.The oxygenator inlet and outlet pressures at the time the issue occurred were unknown.The initiation of support was at 1049, and the issue occurred at 1133.It was said the device would not be returned for evaluation.The value of the act/ptt was 291.The patient was transferred and was said to be deceased.
Additional Manufacturer Narrative
No further info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
No further info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Event or Problem Description
The value of the act/ptt was 144 seconds (1011, pre-ecmo initiation), 291 seconds (1044, pre-ecmo initiation), and 259 seconds (1125, post-ecmo initiation, pre-oxygenator exchange).The patient was transferred to (b)(6) medical center (b)(6) on (b)(6) 2024 at 1630 and was said to be deceased at an unknown date and time.It was said the patient was admitted on (b)(6) 2024 where they experienced pharyngitis with a diffuse rash, developed fever and presented to an outside hospital with severe troponin elevation, diffuse st elevations without chest pain, diabetic ketoacidosis (dka), acute heart failure, and multi-organ failure including shock liver and renal insufficiency, with transthoracic echocardiogram (tte) showing severe biventricular dysfunction.On (b)(6) 2024, it was consulted for venoarterial extracorporeal membrane oxygenation (va ecmo) and the cardiac surgery team agreed.The patient went down to the catheterization lab/hybrid or at 0900 approx.The patient had an impella cp placed less than an hour prior to extracorporeal membrane oxygenation (ecmo) with heparin given in the catheterization lab, and upon arrival to the hvor, an act of 144 was recorded at 1011.Heparin 5,000 units was administered per protocol, and va ecmo was initiated at 1049.Shortly after initiation, the oxygenator failed and required replacement, which was performed at 1133; an additional 10,000 units of heparin were given with a subsequent act of 291.Spo2 tracings were unavailable after ecmo start.On arrival to the hvcc at 1300, ecmo flows remained limited to a maximum of 3.4 l/min at 4500 rpm despite the new oxygenator, and the patient was later transferred to beth israel for heart transplant evaluation, with no further issues reported regarding the replacement oxygenator.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report that the oxygenator clotted could not be confirmed as no product or images were available.A specific cause for the reported events could not be conclusively determined through this evaluation, and a direct correlation with the eurosets oxygenator could not be conclusively established.The eurosets oxygenator, lot number 010058508, was not returned for evaluation.Multiple requests for additional information regarding this event were submitted to the account; however, no response has been received at this time.The production documentation for the eurosets oxygenator, lot number 010058508, was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.Based on the information provided, eurosets determined that there was no correlation between the occurred event and the eurosets device.The eurosets amg pmp instructions for use (ifu), document eu10153, rev.05, is currently available.Under ¿risks and side effects,¿ the ifu lists possible risks and side effects, including thrombosis/oxygenator clotting.These are potential side effects of all extracorporeal blood circulation systems.Under the list of warnings, the ifu warns that during use, a spare oxygenator must always be available.The ifu also warns that the patient and device must be carefully and continuously checked by qualified healthcare professionals throughout the procedure.Strictly monitor the device pressure gradient and gas transfer performances.The ifu also includes the following warnings related to anticoagulation: ¿ before the cardiopulmonary bypass, administer to the patient an adequate dosage of anticoagulant, and adjust dosage through monitoring during and after the bypass.¿ weigh up the benefits of extracorporeal circulation against the risk of systemic anticoagulation.¿ it is recommended to monitor blood coagulation parameters during bypass, in particular, activated clotting time (act), prothrombin time (pt), activated partial thromboplastin time (aptt), fibrinogen.¿ an appropriate monitoring system of coagulation, based on each centre facilities (e.G.Act, aptt, pt) should be established.The anticoagulation therapeutic range should be based on an appropriate coagulation monitoring system relying on more than one parameter.¿ dependent upon other underlying coagulation changes, the act may both underestimate and overestimate the unfh effect in patients, which has the potential to lead to either supratherapeutic anticoagulation and bleeding as well as subtherapeutic anticoagulation and possible thrombosis.Therefore, it is recommended to follow the local hospital procedure for unfh dosage.Note: heparin may induce heparin-induced thrombocytopenia (hitt).Absence of adequate anticoagulation may result in clotting within the system and consequently occlusion of the extracorporeal circuit and the patient circuit.This can lead to inadequate patient support, thrombus formation, hemolysis, hemostasis and ischemia.As the particular rheological blood properties of individuals are not fully known in presence of anticoagulation therapy, conditions of hemorrhage or thrombosis that are difficult to control may occur.Thrombosis situation may lead to a possible marked decrease of the blood-gas exchanger performances (device thrombosis detectable through significant pressure drop, with consequent decreased blood flow and reduced gas exchange).Under the section titled ¿during bypass,¿ the ifu instructs to monitor activated clotting time (act), prothrombin time (pt), activated partial thromboplastin time (aptt), and fibrinogen.This section warns that the act (activated coagulation time) must always be =480 seconds to ensure adequate anticoagulation of extracorporeal circuit.Under the section titled ¿oxygenator replacement,¿ this document states that a spare oxygenator must always be available during perfusion.After 6 hours of use with blood or if particular situations occur, which may lead the person responsible for perfusion to determine the safety of the patient may be compromised (insufficient oxygenator performance, leaks, abnormal blood parameters, etc.), follow the procedure outlined in the ifu for oxygenator replacement.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EUROSETS S.R.L.; strada statale 12, n°143; medolla, modena CA 41036 ; IT 41036
• Manufacturer (Section G): EUROSETS S.R.L.; strada statale 12, n°143; medolla, modena 41036 ; IT 41036
• Manufacturer Contact: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23722008
• Report Number: 3003752502-2025-00051
• Device Sequence Number: 18260129
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: (01)08034013782020(10)10058508(17)270505
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 010058508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 12/16/2025; 03/25/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/15/2025; 01/12/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Death; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Unknown
• Patient Weight: 125 KG