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

Model Number	US5087
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
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
It was reported through ufr (b)(4) that while assessing the extracorporeal membrane oxygenation (ecmo) circuit and oxygenator, the fibers in the oxygenator were bright bloody from a leakage from the outside of the fibers and was quickly growing in surface area.Two blood clots were noted within 30 minutes.Previously, the oxygenator fiber was their baseline color, bloody white.Pictures of oxygenator were sent to the perfusionist on call and the oxygenator was shown to the pediatric intensive care unit (picu) attending.The perfusion spoke with the picu attending, came to patient's room to visualize oxygenator.Many discussions were had with multiple providers about the oxygenator.The decision was made to change out ecmo circuit around 0730.The patient remained stable with stable arterial blood gas (abg) throughout the night.The perfusion isolated the oxygenator after circuit change.
Additional Manufacturer Narrative
D1 and g3 - correction.No further info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Event or Problem Description
The blood flow and gas flow rate was unknown.The oxygenator inlet and outlet pressures at the time the issue occurred was unknown since it was not monitored.The issue occurred at an unknown moment after initiation of support.It was unknown if the device would be returning for evaluation.The pump motor speed (rpm) was unknown.The act/ptt was unknown status post the ross procedure.There were no issues during priming of the oxygenator prior to support.The source of the leak was unknown.No blood was dripping from the oxygenator.No photos or videos of the leak/drip were available.No photos of the thrombus/clot were available.It was confirmed with the chief perfusion who added the attached email with further information.After a phone call with the perfusionist, for what it is worth, the chief perfusionist did not determine the oxygenator to be of fault.This seemed like a user error or lack of education and inexperience and was an unnecessary change out.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported blood clots could not be confirmed as no product or images were provided.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 pediatric oxygenator, lot number 9276700, was not returned for evaluation.The production documentation for the eurosets pediatric oxygenator, lot number 9276700, was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.Based only on the information provided by the customer, eurosets determined that this kind of issue is not considered a fault in the oxygenator because the clots formation cannot be due to the device itself.Eurosets determined that there was no correlation between the reported event and the eurosets device.The eurosets pediatric oxygenator instructions for use (ifu) warns that during use, a spare oxygenator is necessary and warns that the device must be carefully and continuously checked by qualified healthcare professionals.Strictly monitor the device pressure gradient and gas transfer performances.The ifu lists possible risks and side effects, including thrombosis/oxygenator clotting.These are potential side effects of all extracorporeal blood circulation systems.The ifu also recommends monitoring blood coagulation parameters during bypass.Absence of adequate anticoagulation may result in clotting within the system and consequently occlusion of the circuit.The ifu also states that 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.The production documentation for the eurosets pediatric oxygenator, lot number 9276700, was reviewed by the external manufacturer (eurosets) and showed that all tests made in the production process were compliant with the technical specifications.The eurosets pediatric oxygenator instructions for use (ifu) 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 recommends monitoring blood coagulation parameters during bypass.Absence of adequate anticoagulation may result in clotting within the system and consequently occlusion of the circuit.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 ¿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 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: 23881925
• Report Number: 3003752502-2025-00057
• Device Sequence Number: 9605267
• Product Code: DTZ
• UDI-Device Identifier: 08052705493351
• UDI-Public: (01)08052705493351
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K202206
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2026
• Device Model Number: US5087
• Device Catalogue Number: US5087
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 01/21/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/15/2026; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2023
• 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
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Weight: 19 KG