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	11/06/2025
Type of Reportable Event	Malfunction
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 reported that during circuit set up and priming, the neonate oxygenator started leaking priming solution from the purge line connection to the oxygenator.A second neonate oxygenator was then swapped and primed and that was noted to have a slow leak of priming fluid.A third oxygenator was then set up and that did not have a leak.
Event or Problem Description
Additional information received stated that for the first oxygenator that leaked from the purge line connection, the leak was noticed the following day.For the second oxygenator with a slow leak of priming fluid (b)(6), the leak was noticed right after priming was completed.The same priming technique was used on all three oxygenators.For the third oxygenator that was leaking, the leak was noticed the following day after the circuit was primed.The source of the leak was the purge line connection point.This was the same location for all three oxygenators.The pump speed for all three oxygenators was 1500 rpms with 1.5 lpm of flow for about a couple minutes.
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: functional testing of the returned oxygenator by the external manufacturer (eurosets) was unable to confirm the reported oxygenator leak.A specific root cause for the reported event could not be conclusively determined through this evaluation.It was reported that during circuit set up and priming, the oxygenator started leaking priming solution from the purge line connection to the oxygenator.Pump speed was reportedly 1500 revolutions per minute (rpm) with 1.5 liters per minute (lpm) of flow for about a couple minutes.A second oxygenator was then swapped in.The oxygenator was returned to abbott where an initial visual inspection was performed.Visual inspection of the oxygenator revealed no obvious damage that would have caused the reported event.The oxygenator was forwarded to eurosets for technical analysis.The oxygenator was placed on a mock loop with physiological water and remained in the loop for 3 hours at 1 atmosphere (atm) of pressure.During this time, no leakage was noticed.The production documentation for the eurosets infant oxygenator, lot #10453300, was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.Eurosets confirms that the 100% production process is applied to all devices.Based on the technical investigation, it was confirmed that the devices were compliant with the technical specifications; therefore, the reported event was unable to be confirmed.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.Incidental finding: the tubing of the blood outlet port appeared to be deformed.The production documentation for the eurosets new born oxygenator, lot #10453300, 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 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.

• 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: 23623739
• Report Number: 3003752502-2025-00042
• Device Sequence Number: 10091067
• Product Code: DTZ
• UDI-Device Identifier: 08052705493368
• UDI-Public: (01)08052705493368(10)10453300(17)270709
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2026

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: 10453300
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 03/17/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/22/2025; 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• 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
• Patient Sex: Unknown