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	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the oxygenator was primed and was leaking from the top; there was rapid condensation at the top dripping out of the bottom of the oxygenator.There were no alarms.The oxygenator was cut away and replaced.
Additional Manufacturer Narrative
A1-a4: there was no patient involved.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
The leak was found when it was checked before use on a patient.The circuit was primed 2 days prior to the leak being noted.The leak seemed to be internal in the heater fluid channel.The pump was running at around 2000 rpms and the priming fluid was plasmalyte.No inlet/oulet pressures were monitored at that time.There were no photos or videos were taken.
Additional Manufacturer Narrative
B5 narrative info.D4 - additional device information no further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Section d1 - brand name: corrected.Section d4 - model number: corrected.Section d4 - catalog number: corrected.Manufacturer's investigation conclusion: the returned oxygenator was found to be compliant with the technical specification, and no device issues were identified through this evaluation.Evaluation of the returned oxygenator found no obvious cracks or damage to the external housing, ports, or fibers.Clear drops of liquid were noted in the top and bottom housing that may have been related to the reported event or the condition of the device during its return to abbott.It was noted that if condensation had formed on the top housing, it could have dripped through to the bottom housing through the gas pathway.The oxygenator was forwarded to the supplier (eurosets) for technical analysis.The oxygenator was placed on a mock loop with physiological water, filled using a peristaltic pump at 6 liters per minute (lpm), and remained in the mock loop for 6 hours.During this time, the oxygenator did not leak.Based on the investigation, eurosets confirmed that the oxygenator was compliant with the technical specification, and no issues were identified.The relevant sections of the device history records for the centrimag adult extracorporeal membrane oxygenation (ecmo) kit (cmaek), serial #(b)(6), were reviewed and showed no relevant deviations from manufacturing or quality assurance specifications.The centrimag pre-connected pack instructions for use (ifu) 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.-frequently monitor the patient and circuit.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.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 20250761
• Report Number: 3003752502-2024-00029
• Device Sequence Number: 7363090
• Product Code: DTZ
• UDI-Device Identifier: 05415067036414
• UDI-Public: (01)05415067036414(17)240927
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/22/2025

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: 09/27/2024
• Device Model Number: CMAEK00
• Device Catalogue Number: CMAEK00
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 11/04/2024; 01/21/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 11/24/2024; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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