MAUDE Adverse Event Report: EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE; Oxygenator, Cardiopulmonary Bypass

Model Number	US5062
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582); Hemodynamic instability (4868)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that per the clinician, about an hour and a half after initiating support, there was blood noted to be coming from the bottom of the oxygenator where the base of the egress meets the heat exchanger.The blood was wiped clean and thought to be coming from a connection however, the issue persisted as a slow bleed throughout the shift.The oxygenator safely exchanged and considered out of box failure.
Additional Manufacturer Narrative
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 completed.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was additionally reported that no issues were noted during priming.No leaking of crystalloid was noted during routine check of the primed pump.The patient was unstable and had to be off of venoarterial extracorporeal membrane oxygenation (va ecmo) for the circuit exchange but tolerated it well with increased pressors.The leakage seemed intermittent; initially the source was thought to be from a pigtail which was changed out.The leakage was from the inside of the blue portion on the bottom of the oxygenator.The new oxygenator worked fine.No infectious risk was noted.

• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24241502
• Report Number: 3003752502-2026-00006
• Device Sequence Number: 9183659
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: (01)08034013782020(10)11585208(17)280604
• 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
• 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): 09/29/2026

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: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 11585208
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2026
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 03/04/2026; 09/28/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/18/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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