MAUDE Adverse Event Report: EUROSETS S.R.L. STANDALONE PMP NEONATAL OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	US5088
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a: there was no patient involvement.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 the neonate oxygenator had a leak and was replaced.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: functional testing of the returned oxygenator by the manufacturer (eurosets) confirmed an oxygenator leak due to fiber breakage; however, a specific root cause for the fiber breakage could not be conclusively determined through this evaluation.The oxygenator was returned to abbott where an initial visual inspection was performed.Droplets of clear liquid were noted in the bottom housing, within the gas pathway; however, it was unknown if the droplets were related to the reported priming leak.The oxygenator was forwarded to the external manufacturer (eurosets) for technical analysis.The oxygenator was placed on a mock loop with physiological water.The oxygenator was filled using a peristaltic pump at 6 liters per minute (lpm) and remained in the mock loop for 10 minutes.A slow drip in the lower part of the oxygenator was confirmed.The device was sectioned by removing the upper lid, refilled with water, and pressurized.The point of loss occurred due to the fiber breakage of the last winding at the blood arterial outlet connection.The device history record for the eurosets infant oxygenator, lot number 09587500, was reviewed by the external manufacturer (eurosets).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.Eurosets confirmed that 100% of the oxygenators produced are tested to detect eventual leakages using a pressure of 150 kpa (kilopascals) which is 1.5 times the maximum blood pathway pressure indicated on the ifu (instructions for use).Devices that exhibit leaks are discarded prior to distribution.Eurosets determined that the issue occurred after eurosets¿ manufacturing and test phases.Eurosets communicated that their production process and controls will continue to be improved to further reduce the occurrence rate of these events, which will also be monitored for adverse trends.Incidental findings: the blood inlet port appeared to be deformed.The device history record for the eurosets infant oxygenator, lot number 09587500, was reviewed by the external manufacturer (eurosets); 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.The eurosets amg pmp infant cardiopulmonary bypass oxygenator instructions for use (ifu) is currently available.The ifu includes warnings that: the device is intended to be used by professionally trained personnel.That the extracorporeal circulation has to be carefully and continuously checked by qualified healthcare professionals throughout the procedure.To carefully check the device seal during priming and operation.If you notice leakage during priming or operation, replace the defective device following good perfusion practices.That during use, a spare a.M.G.Pmp infant oxygenator must always be available.Under the section titled ¿set up¿, the ifu warns to carry out a visual inspection and carefully check the device before use.Transport and/or storage conditions other than those prescribed may have caused damage to the device.This section also instructs to check that all connections are properly secured.No further information was provided.The manufacturer is closing the file on this event.
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
It was additionally reported through mw5178980 that the oxygenator leaked fluid from the oxygenator module.This was observed while priming prior to initiating support and was promptly changed before the patient was placed on extracorporeal membrane oxygenation (ecmo).The oxygenator was never used on a circuit attached to a patient.The oxygenator was not exposed to blood.

• Brand Name: STANDALONE PMP NEONATAL OXYGENATOR
• 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: 23648701
• Report Number: 3003752502-2025-00047
• Device Sequence Number: 21363239
• Product Code: DTZ
• UDI-Device Identifier: 08052705493368
• UDI-Public: (01)08052705493368(10)09587500(17)261016
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K202510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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: US5088
• Device Catalogue Number: US5088
• Device Lot Number: 09587500
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 04/03/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/29/2025; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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
• Patient Sex: Unknown