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	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the when the new circuit was primed, a whistling sound was heard coming from the oxygenator.The oxygenator was removed from the circuit and replaced with a new oxygenator.All other components were the same.There was no whistling sound after the oxygenator was replaced.
Additional Manufacturer Narrative
A4 - patient weight not yet provided.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
There was no whistling sound after the oxygenator was replaced.When whistling sound occurred, priming fluid flow was at 4lpm, and there was no pressure monitoring.It was also noted that no patient was involved in the event.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: functional testing of the returned oxygenator, serial number (b)(6), confirmed a high-pitched sound.Although a specific root cause for this finding could not be conclusively determined through this evaluation, there was no report or indication of an issue with the performance of the oxygenator related to gas exchange or pressure.The oxygenator was returned to the abbott facility in burlington, massachusetts where an initial visual inspection was performed.Tubing was present on the blood inlet and outlet ports.A small amount of fluid was present and blood inlet and outlet ports, consistent with reported priming.No obvious damage to the device was observed.Visual inspection did not confirm an issue that would have contributed to the reported event.The oxygenator was placed in a mock loop with a test centrimag pump and water.A high-pitched sound was confirmed while the pump was ran at the reported speed and flow.The sound appeared to become lower in volume when flow was decreased via a tubing clamp.The device history record for the oxygenator was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.No abnormalities were documented which would have caused or contributed to the reported occurrence.This device passed all required testing.The production documentation for the eurosets amg pmp oxygenator, lot number 011336108, 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) 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.
Event or Problem Description
It was reported that revolutions per minute were at 3000 when the whistling sound occurred.

• 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 CA 41036 ; IT 41036
• Manufacturer Contact: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23561653
• Report Number: 3003752502-2025-00041
• Device Sequence Number: 15910027
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: (01)08034013782020(10)11336108(17)280401
• 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,Followup
• Report Date (Section B): 02/16/2026

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: Lay User/Patient
• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 011336108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: Not provided; 02/11/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 01/06/2026; 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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