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

Model Number	US5062
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that clots on the top of the oxygenator were noticed on day 2 and those clots continued to grow.On day 8, they electively changed the oxygenator without incident.There were no changes to anticoagulation that could have contributed to the event and no adverse patient impact.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of clots in the oxygenator was unable to be confirmed through the submitted image, and the product was not available for evaluation.A specific root cause of the event was unable to be conclusively determined through this evaluation.The eurosets oxygenator would reportedly not be returned for evaluation.The production documentation for the eurosets amg pmp oxygenator, lot number: 10276308, was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.Devices are required to pass manufacturing inspections and specifications prior to release and no abnormalities were documented which would cause or contribute to the reported occurrence.This device passed all required testing.Based only on the available information, eurosets was unable to identify the root cause of the problem.Additionally, eurosets was unable to identify any clots from the submitted image.The production documentation for the eurosets amg pmp oxygenator, lot number: 10276308, 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 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.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.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 21867846
• Report Number: 3003752502-2025-00015
• Device Sequence Number: 18122019
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: (01)08034013782020(10)10276308(17)270305
• 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
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 08/14/2025

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: 10276308
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White