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	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that once the extracorporeal membrane oxygenation (ecmo) circuit was primed, a high-pitched whistle sound came from the oxygenator when flows were above 2.0 l/min.The customer made sure the circuit and oxygenator were fully de-aired and tried to run the pump again but had the same whistle sound.At the time of the issue, the gas line was not connected, and pressures were not measured.Pump flow when the whistling occurred was constant between 2.0-5.0 liters.The oxygenator was removed from the circuit and a second oxygenator was used in the circuit.The event resolved with the exchange.The second oxygenator was primed and used with no issues.The customer did not record any video of the incident.
Additional Manufacturer Narrative
Section d4: expiration date and manufacture date (h4) could not 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.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: although the reported whistling was unable to be conclusively confirmed, functional testing of the returned oxygenator by the manufacturer (eurosets) found that the device was compliant with the technical specifications.The oxygenator was returned to abbott where an initial visual inspection was performed that revealed no obvious abnormalities.The oxygenator was then forwarded to the external manufacturer (eurosets) for investigation.The production documentation for the oxygenator was reviewed by the supplier (eurosets), and it was confirmed that all tests from the production process were compliant with the technical specifications.The production process test is applied to 100% of the devices.A functional test of the oxygenator was performed by eurosets on a test circuit with bovine blood and found that the oxygenator was compliant with the reference values.Eurosets concluded that the technical investigation confirmed that the claimed device was compliant with the technical specification and for that reason they were not able to confirm the complaint.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 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.The production documentation for the eurosets oxygenator, lot number 10908708, was reviewed by the external manufacturer (eurosets) and showed that all tests made in the production process were compliant with the technical specifications.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: 22370997
• Report Number: 3003752502-2025-00025
• Device Sequence Number: 20821489
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: (01)08034013782020(10)10908708(17)280224
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 10908708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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