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	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were issues with two oxygenators leaking from the purge line.The extracorporeal membrane oxygenation (ecmo) circuits were kept primed and ready for extracorporeal cardiopulmonary resuscitation (ecpr), and during the routine checks it was noticed that there was moisture around the purge line coming off the top of the oxygenators.It was attempted to tighten the connection, but it continued to leak which led to the two oxygenators needing to be replaced.
Additional Manufacturer Narrative
Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.Section g4: there was no patient involved in this event.The pma # provided is associated with the device¿s most recent approval.No further information was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.

• 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 ; +1(781)852-8207
• MDR Report Key: 50194922
• Report Number: 3003752502-2026-00036
• Device Sequence Number: 18644327
• Product Code: DTZ
• UDI-Device Identifier: 08052705493368
• UDI-Public: (01)08052705493368
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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
• Was Device Available for Evaluation?: No
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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