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

Model Number	CMAEK00
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Gas/Air Leak (2946); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Section a - no patient information was provided.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 the pre-connected pack had entrapped air during the priming process, seemingly causing the pump to malfunction.The pre-connected pack was being prepped by less comfortable staff that seemed to entrap a fair amount of air in the circuit causing the pump to shut down.This was not deemed a device failure by the practitioners.
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
After further speaking with the clinicians, they did not fault the device at all.The patient was noted to be critically ill and had many underlying conditions.The physicians did not want to pursue this as a device failure and did not wish to explore this further.No product would be returned.No log files were available.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: there were no device related issues with the centrimag pre-connected pack reported or identified through this evaluation.The centrimag pre-connected pack was not returned for evaluation.Device history records could not be reviewed due to the serial/lot number of the centrimag preconnected pack being unavailable.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.-frequently monitor the patient and circuit.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 22161651
• Report Number: 2916596-2025-03320
• Device Sequence Number: 21003362
• Product Code: DTZ
• UDI-Device Identifier: 05415067036414
• UDI-Public: (01)05415067036414
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 08/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CMAEK00
• Device Catalogue Number: CMAEK00
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 08/27/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 08/07/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown