MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG ADULT ECMO KIT (US); OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	CMAEK00
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
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 while priming the pre-connected extracorporeal membrane oxygenation (ecmo) kit, a leak and hole was noted in the reservoir bag.The priming procedure was aborted and the pre-connected pack was placed to the side.The circuit was not used to support a patient.
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: review of the submitted video confirmed the reported leak through a hole in the priming bag; however, a specific cause for the priming bag damage could not be conclusively determined.Manufacturing investigation identified that current manufacturing procedures at abbott do not call for a physical defect inspection of the priming bag; therefore, the reported issue was classified as manufacturing related.The centrimag pre-connected pack, serial #(b)(4) was not returned for evaluation; however, a video was submitted.Review of the submitted video found that the priming bag was filled with a clear liquid.The clear liquid was slowly dripping from the priming bag through an apparent hole approximately an inch from the seam/side of the bag.The supplier of the priming bag (eurosets) reviewed the production documentation for the priming bag and found that all tests from the production process were compliant with the technical specifications.Eurosets confirmed that all bags undergo 100% of the required leak tests, in order to detect any non-conformities before release both on the seals and on the priming bag sheet material.Devices that exhibit leaks are discarded prior to distribution, and no anomalies or sealing defects were found on the bag under investigation.Eurosets determined that the reported leak during the priming phase did not appear related to a manufacturing defect.Furthermore, eurosets reported that no additional reports have emerged from the market regarding similar issues with the same type of product or batch.Further investigation of the reported issue was initiated through a manufacturing analysis task.Although the specific cause for the hole in the priming bag causing a leak could not be conclusively determined through the root cause evaluation, it was found that the procedures at abbott pleasanton site do not call for a physical defect inspection.Therefore, a visual inspection step for detecting a hole in the priming bag was added to the manufacturing procedures.The relevant sections of the device history record (dhr) for the centrimag pre-connected pack, serial number (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag pre-connected pack instructions for use (ifu) is currently available.The document provides instructions for priming the centrimag pre-connected pack using the priming bag.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.-if a pack component is dropped and damaged, replace the pack.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: CENTRIMAG ADULT ECMO KIT (US)
• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 22136372
• Report Number: 2916596-2025-00019
• Device Sequence Number: 8354282
• Product Code: DTZ
• UDI-Device Identifier: 05415067036414
• UDI-Public: (01)05415067036414(17)260923
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/26/2026

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 Expiration Date: 09/23/2026
• Device Model Number: CMAEK00
• Device Catalogue Number: CMAEK00
• Device Lot Number: 10623553
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2024
• 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