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

Model Number	CMAEK00
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
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 the patient had been on venoarterial extracorporeal membrane oxygenation (va ecmo) support for about 5 hours when bedside staff noticed blood trickling down from the bottom of the oxygenator.The ecmo settings were rotations per minute (rpm) 4000, blood flow rate (bfr) 3.3 liters, fraction of inspired oxygen (fio2) 100%, sweep 4 and recent arterial blood gas (abg) ph 7.49, pco2 25, po2 389 and bicarbonate 18.6.The ecmo circuit was cut out and replaced with a new pre-connected pack.
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
No product would be returned as all the blood residue couldn't be removed from the circuit.The product could possibly contain biological residue of who risk group 4 or 3 such as avian flu, sars-cov-2 etc.The product could also possibly contain biological residue of who risk group 1 or 2 (non-infectious substance) like adeno-associated virus (aav) types 1 through 4, clamydiae, e-coli etc.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: review of the submitted images confirmed an accumulation of blood in the oxygenator housing consistent with a blood leak; however, a specific cause for the blood leak could not be conclusively determined through this evaluation.Review of the submitted image showed an accumulation of blood with bubbles in the bottom housing of the oxygenator, within the gas pathway.The oxygenator from centrimag pre-connected pack, serial #(b)(6), was not returned for evaluation.The centrimag pre-connected pack instructions for use (ifu) warns to frequently monitor the patient and circuit.The ifu warns to monitor the circuit for leaks or other product anomalies.Replace the pack if it does not operate as expected.The ifu warns to not use excessive or damaging force when handling the pack; if a pack component is dropped and damaged, replace the pack.The ifu also warns that a backup pack must be available immediately near the primary pack during support.The production documentation for the centrimag adult extracorporeal membrane oxygenation (ecmo) kit (cmaek) oxygenator, serial #(b)(6), (eurosets part #us5591; lot #7404304) was reviewed by the supplier (eurosets), and it was confirmed that all tests from the production process were compliant with the technical specifications.The relevant sections of the device history record (dhr) for the cmaek, serial #(b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.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.Monitor the circuit carefully during use for any signs of occlusion from kinks, chattering, and clot formation.Pack replacement should be prescribed by the physician based on risks and benefits to the patient.If a pack component is dropped and damaged, replace the component.Under the section titled "prime the circuit," the ifu warns to monitor the circuit for leaks or other product anomalies.Replace the circuit if it does not operate as expected.The current revisions of the ifu can also be found on the electronic ifu (eifu) page of the abbott website.No further information was provided.The manufacturer is closing the file on this events.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 21245760
• Report Number: 3003752502-2025-00004
• Device Sequence Number: 17044444
• Product Code: DTZ
• UDI-Device Identifier: 05415067036414
• UDI-Public: (01)05415067036414(17)260529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141492
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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 Expiration Date: 05/29/2026
• Device Model Number: CMAEK00
• Device Catalogue Number: CMAEK00
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 02/14/2025; 07/30/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 03/04/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 64 KG