MAUDE Adverse Event Report: EUROSETS S.R.L. OXYGENATOR AND TUBING PACK KIT, ADULT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	14AG70131
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
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 completed.
Event or Problem Description
It was reported that upon entering extracorporeal membrane oxygenation (ecmo), it was noted that blood was coming out of the oxygenator.A new system was set up and no patient consequences occurred.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the returned oxygenator confirmed a leak consistent with fiber breakage; however, a specific cause for the fiber breakage could not be conclusively determined through this evaluation.The cmaek oxygenator, serial #(b)(6), was returned, and a visual inspection was performed.There was no obvious cracks or damage to noted; however, dried blood was noted in the bottom blue housing, within the gas pathway of the device.The cmaek oxygenator was placed in a mock loop using a test centrimag pump with saline flow of approximately 2.5 lpm.Dripping from bottom of the fibers beneath the blood outlet port was noted.After removal of bottom housing, the leak was confirmed from the bottom of the outer winding of fibers, consistent with fiber breakage.A specific cause for the fiber break could not be conclusively determined through this evaluation.Additional investigation of oxygenator leaking issues has been initiated by abbott and sent to eurosets (oxygenator supplier/manufacturer) through a supplier corrective action request.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.Additionally, the production documentation of the oxygenator within the kit (eurosets part #us5591; lot #7694904) was reviewed by the supplier (eurosets), and it was confirmed that all tests from the production process were compliant with the technical specifications.The centrimag adult extracorporeal membrane oxygenation kit instructions for use (ifu), rev.C, is currently available.The ifu contains the following general warnings: -only trained personnel should use the circuit.-a backup circuit must be available immediately near the primary circuit during ecmo support.-do not use excessive or damaging force when handling the circuit.-frequently monitor the patient and circuit.Monitor the circuit carefully during use for any signs of occlusion from kinks, chattering, and clot formation.-component replacement should be prescribed by the physician based on risks and benefits to the patient.-if a circuit 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.No further information was provided.The manufacturer is closing the file on this event.
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
Additional information was received that the speed was around 3000 rpm and the flow was around 2.5 lpm.The patient's activated clotting time (act) was around the 200s.The source of the leak was able to be identified.

• Brand Name: OXYGENATOR AND TUBING PACK KIT, ADULT
• 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: 19588820
• Report Number: 2916596-2024-04056
• Device Sequence Number: 3340796
• Product Code: DTZ
• UDI-Device Identifier: 05415067036414
• UDI-Public: (01)05415067036414(17)241104
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2024

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: 11/04/2024
• Device Model Number: 14AG70131
• Device Catalogue Number: 14AG70131
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 12/19/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 11/12/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2023
• 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