MAUDE Adverse Event Report: EUROSETS S.R.L. CENTRIMAG ADULT ECMO KIT (US); OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	CMAEK00
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that centrimag adult extracorporeal membrane oxygenation (ecmo) was cracked and leaking blood.The crack was at the base of the oxygenator above where the inlet (venous blood) came into the oxygenator.The unit was exchanged.
Additional Manufacturer Narrative
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 the issue occurred immediately after the initiation of the support.The patient did not have any adverse effect.It was unknown how the oxygenator become cracked.The crack was lower third of the oxygenator, between the heater/cooler hook ups.No issues were noted during priming, which was done prior to treatment.No photos or videos would be provided.
Additional Manufacturer Narrative
Section g4: there was no patient involved in this event.The pma # provided is associated with the device¿s most recent approval.Manufacturer's investigation conclusion: the reported crack and blood leak could not be confirmed as no product or images were provided for evaluation.A specific root cause for the reported event could not be conclusively determined.The oxygenator from the centrimag pre-connected pack, serial number 20457878, was not returned for evaluation.The centrimag pre-connected pack instructions for use (ifu) rev.B, is currently available.The ifu contains the following general warnings: -only trained personnel should use the pack.-a backup pack must be available immediately near the primary pack during support.-do not use excessive or damaging force when handling the pack.-frequently monitor the patient and circuit.-if a pack component is dropped and damaged, replace the component.Under the section titled ¿prime the centrimag pre-connected pack,¿ the ifu warns to monitor the circuit for leaks or other product anomalies.Replace the pack if it does not operate as expected.The relevant sections of the device history record (dhr) for the centrimag adult extracorporeal membrane oxygenation (ecmo) kit (cmaek), serial # (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The production documentation for the cmaek oxygenator (eurosets part #us5591; lot #7887204) was reviewed by the supplier (eurosets), and it was confirmed that all tests from the production process were compliant with the technical specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG ADULT ECMO KIT (US)
• 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: 23322591
• Report Number: 3003752502-2025-00035
• Device Sequence Number: 9938204
• Product Code: DTZ
• UDI-Device Identifier: 05415067036414
• UDI-Public: (01)05415067036414(17)270205
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222297
• 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): 01/30/2026

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: CMAEK00
• Device Catalogue Number: CMAEK00
• Device Lot Number: 7887204
• Was Device Available for Evaluation?: No
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 01/29/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/22/2025; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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