MAUDE Adverse Event Report: THORATEC CORPORATION ADULT OXYGENATOR, PMP, ABBOTT-BRANDED, PRIESTLEY; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	100174772
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
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 immediately after priming of a new pre-connected pack the extracorporeal membrane oxygenation (ecmo) coordinator noted leaking of the priming fluid out of the blue gas exhaust while the centrimag was not running.The circuit was not on a patient and there was no delay in care.The circuit was removed and set aside.A new pre-connected pack was opened and primed without issue.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: functional testing of the returned oxygenator confirmed a leak due to fiber breakage; however, a specific root cause for the fiber breakage could not be conclusively determined through this evaluation.The oxygenator, lot number: 8167873, within the centrimag pre-connected pack, serial number: (b)(6), was returned, and a visual inspection was performed.The oxygenator had the purge line connected to its port, and the pre-connected tubing was connected to the blood inlet and outlet ports with ties.Visual inspection of the oxygenator revealed no obvious cracks or damage to the fibers, ports, or external housing.Drops of clear liquid were noted in the bottom housing of the oxygenator, within the gas flow pathway.The oxygenator was forwarded to the oxygenator supplier/manufacturer (eurosets) for supplier technical analysis.The oxygenator was placed on a mock loop with physiological water.The oxygenator was filled using a peristaltic pump at 6 liters per minute (lpm) and remained in the mock loop for 10 minutes.A slow drip in the lower part of the oxygenator was confirmed.The device was sectioned by removing the lower housing, refilled with water, and pressurized.The point of loss occurred due to the fiber breakage near the blood outlet port.The supplier production documentation for the oxygenator was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.Devices are required to pass manufacturing inspections and specifications prior to release, and no abnormalities were documented which would cause or contribute to the reported occurrence.This device passed all required testing.Eurosets confirmed that 100% of the oxygenators produced are tested to detect eventual leakages using a pressure which is 1.5 times the maximum blood pathway pressure indicated on the ifu (instructions for use).Devices that exhibit leaks are discarded prior to distribution.Eurosets determined that the issue occurred after eurosets¿ manufacturing and test phases.Eurosets communicated that their production process and controls will continue to be improved to further reduce the occurrence rate of these events, which will also be monitored for adverse trends.Additional investigation of oxygenator leaking issues has been initiated by abbott and sent to eurosets through a supplier corrective action request.The relevant sections of the device history record (dhr) for the oxygenator, lot number: 8167873, within the centrimag pre-connected pack, serial number: (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The production documentation for the oxygenator, eurosets lot number: 7815004, were reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical 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.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 pack.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 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 event.

• Brand Name: ADULT OXYGENATOR, PMP, ABBOTT-BRANDED, PRIESTLEY
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 21315534
• Report Number: 2916596-2025-00787
• Device Sequence Number: 15507423
• Product Code: DTZ
• UDI-Device Identifier: 05415067036414
• UDI-Public: (01)05415067036414(17)260626
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 11/26/2025

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: 06/26/2026
• Device Model Number: 100174772
• Device Catalogue Number: 100174772
• Device Lot Number: 8167873
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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 Sex: Unknown