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

Model Number	CMAEK00
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
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 the patient was on veno-arterial extracorporeal membrane oxygenation (va-ecmo) support with an impella.They were on support for 4 days.After an advanced membrane gas exchange oxygenator was added the pao2 went from 310 to 125 overnight.A new oxygenator was spliced into the circuit and had a post-pao2 of 120.The oxygenator was exchanged.It was requested that new oxygenators were sent to the hospital because there was concern about a "bad batch" of oxygenators.
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 following standard evaluation of circuit gases and follow up evaluation utilizing an alternate testing modality, the air flow access from the wall to the blender was verified and it was ensured that all access sites were connected appropriately.The integrity of the green gas line/disk connecting the blender to the oxygenator was confirmed.Eventually, the blender was removed entirely and the oxygenator was connected to a full tank, which did not resolve the issue.The fio2 was 1.0.The patient's partial thromboplastin time (ptt) was 87.8 at the time of oxygenator exchange.Their 24 hour range was 87.8-155.
Additional Manufacturer Narrative
Correction: section d3 and g were updated to the correct manufacturer.This report should be cfn based and the first part of the mfr # should be 2916596.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: device information corrected.Manufacturer's investigation conclusion: the report of a decrease in oxygen exchange could not be confirmed as the device was not returned for evaluation, and a specific root cause for the reported event could not be conclusively determined the centrimag adult extracorporeal membrane oxygenation (ecmo) kit (cmaek), serial number (b)(6), was not returned for evaluation.The production documentation for the centrimag adult extracorporeal membrane oxygenation (ecmo) kit (cmaek) oxygenator, serial #(b)(6), (eurosets part #us5591; lot #8518404) was also 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.Review of the dhr for the centrimag (cm) blood pump, lot number l08292-la4, also revealed no deviations from manufacturing or quality assurance specifications.The centrimag pre-connected pack instructions for use (ifu) is currently available.The ifu lists potential adverse events associated with the use of any extracorporeal circuit, including respiratory failure, anoxia, and hypercarbia.The ifu contains the following 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.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.-always monitor oxygen supply and carbon dioxide removal from the circuit.Under the section titled ¿prime the centrimag pre-connected pack,¿ the ifu warns to monitor the circuit for product anomalies.Replace the pack if it does not operate as expected.Under the section titled ¿centrimag pre-connected pack operation,¿ the ifu includes instructions for how to adjust gas mixer values based on blood gas content.This section also notes to regulatory perform gas analyses.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 20643174
• Report Number: 3003752502-2024-00033
• Device Sequence Number: 12618153
• Product Code: DTZ
• UDI-Device Identifier: 05415067036414
• UDI-Public: (01)05415067036414(10)10447110(17)250705
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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: 07/05/2025
• Device Model Number: CMAEK00
• Device Catalogue Number: CMAEK00
• Device Lot Number: 10447110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 03/17/2025; 07/28/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/02/2025; 04/10/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2024
• 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