MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG BLOOD PUMP; BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE

Model Number	102953
Medical Device Problem Codes	Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient was on centrimag (cmag) mechanical circulatory support when the console stopped working.The customer swapped out the cmag console, motor, and monitor for a new set and the customer was placed back on support.It was communicated on (b)(6)2025 that the patient passed away.It was possible that the device issue impacted the patient.
Additional Manufacturer Narrative
Section d4: device lot number was not provided, and expiration date cannot be determined.The primary udi number in d4 is updated with all of the current information available.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was confirmed that the patient passed away on (b)(6) 2025, and they had multiple comorbidities.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported low flow alarms were unable to be confirmed as no log files were available.A specific cause for the reported events could not be conclusively determined, and a direct correlation between the reported events and the centrimag pump could not be conclusively established through this evaluation.Multiple requests for additional information regarding this event were submitted to the account; however, no response has been received at this time, and the centrimag pump was not returned for evaluation.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.The centrimag blood pump instructions for use (ifu) (rev.C) is currently available.The ifu lists death as an adverse event that may be associated with the centrimag circulatory support system under ¿adverse events.¿ the ifu also provides the following warnings and cautions: ifu warning #10: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.The centrimag operating manual (rev.E) is currently available.Section 12.1 entitled "appendix i ¿ console alarms and alerts" in this ifu contains a list of console alarms and alerts, including the f2 and f3 flow alerts, as well as appropriate operator response to these events.The current revisions of the ifu and operation manual 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.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported low flow alerts were confirmed through the retrieved log file.However, a specific cause for the reported events could not be conclusively determined, and a direct correlation between the reported events and the centrimag pump could not be conclusively established through this evaluation.Log files were retrieved from the returned console, and recent/relevant data was reviewed.The log file review confirmed intermittent f2 flow signal interrupted and f3 flow below minimum alerts.Approximately 10 hours after the system was started on the relevant day of data, a system shutdown was captured.Several intermittent m2 motor disconnected alarms and f3 alerts were captured, along with intermittent s3 system alerts and additional system shutdowns/restarts.Refer to the motor evaluation regarding the m2 alarms and s3 alerts.There were no other notable findings in the relevant log file data.Multiple requests for additional information regarding this event were submitted to the account; however, no response has been received at this time, and the centrimag pump was not returned for evaluation.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.The centrimag blood pump instructions for use (ifu) (rev.C) is currently available.The ifu lists death as an adverse event that may be associated with the centrimag circulatory support system under ¿adverse events.¿ the ifu also provides the following warnings and cautions: ifu warning #10: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.The centrimag operating manual (rev.E) is currently available.Section 12.1 entitled "appendix i ¿ console alarms and alerts" in this ifu contains a list of console alarms and alerts, including the m2 motor disconnected, s3 system alert, f2 flow signal interrupted, and f3 flow below minimum alerts/alarms, as well as appropriate operator response to these events.The current revisions of the ifu and operation manual 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 BLOOD PUMP
• Common Device Name: BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE
• 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: 23295947
• Report Number: 3003306248-2025-00288
• Device Sequence Number: 20033189
• Product Code: QNR
• UDI-Device Identifier: 07640135140627
• UDI-Public: (01)07640135140627
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K020271
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/24/2026

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: 102953
• Device Catalogue Number: 102953
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 11/17/2025; 01/14/2026; 06/05/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/08/2025; 01/15/2026; 06/24/2026
• 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 Age: 4 YR
• Patient Sex: Male
• Patient Weight: 18 KG