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

Model Number	US5062
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d4: expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that during priming, a loud noise was noted.A rattling noise was initially reported.The pump was moved to two new systems (motors and consoles).One had the screw in lock, and one had the snap in lock, and the noise was still noted.The pump was exchanged for a new pump and noise still persisted.The whole system was switched with a new advanced membrane gas (amg) oxygenator (old oxygenator was an amg), and the noise went away.It was concluded that the noise, later described as a whistling noise, came from the oxygenator.No patient was involved.It was confirmed that the noise was not from the pump or motor.Pump speed was 1800-2000rpm and priming fluid was 220ml for oxygenator/2 l hung to prime the whole circuit.Pressures were not monitored on their circuits.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a specific cause for the reported noise was unable to be conclusively determined through this evaluation; however, eurosets' investigation of the returned device determined that the device was compliant with the technical specifications.The eurosets advanced membrane gas exchange (amg) polymethylpentene (pmp) oxygenator, lot number 11067008, was returned and an initial visual inspection was performed.Visual inspection of the oxygenator revealed no obvious damage.The amg pmp oxygenator was forwarded to the external manufacturer, eurosets, for technical analysis.Eurosets¿ technical investigation confirmed that the claimed device was compliant with the technical specifications and for this reason eurosets was not able to confirm the complaint by the customer.Eurosets communicated that this event will be monitored within the eurosets trend reporting and in case of adverse trends, further investigation and/or corrective actions will be carried out.The production documentation for amg pmp oxygenator, lot number 11067008, was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.The eurosets amg pmp instructions for use (ifu) is currently available.Under the list of warnings, the ifu warns that during use, a spare oxygenator must always be available and warns that the device has to be carefully and continuously checked by qualified healthcare professionals throughout the procedure.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: 23558843
• Report Number: 3003752502-2025-00038
• Device Sequence Number: 15981111
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: (01)08034013782020(10)11067008(17)280227
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 11067008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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
• Patient Sex: Unknown