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

Model Number	102953
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Insufficient Information (4580)
Date of Event	09/09/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
A.Patient information was not provided by the customer.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 patient had ischemia of the left foot that required medical intervention to prevent injury or permanent disability.
Additional Manufacturer Narrative
Section b3: date of death was not provided.Manufacturer's investigation conclusion: a direct correlation between the centrimag blood pump and the reported events and subsequent patient outcome could not be conclusively established through this evaluation.It was additionally communicated that the serial lot/number of the centrimag blood pump was not available, as the patient was transferred to another hospital after the reported event.The centrimag blood pump was not returned for evaluation.The serial 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), is currently available.The current revisions of the ifu can also be found on the electronic ifu (eifu) page of the abbott website.The ifu lists limb ischemia and death as adverse events that may be associated with the centrimag circulatory support system.This ifu also provides the following warnings and cautions: ifu warning #2: back-up components must always be available.Ifu warning #12: frequent patient and device monitoring is recommended.Do not leave the device unattended during use.Ifu caution #5: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was additionally reported that the ischemia was not device or therapy related.The device operated as expected.The ischemia did not resolve as the patient expired due to other complications, and stopping all therapies.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• 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: 23721521
• Report Number: 2916596-2025-07808
• Device Sequence Number: 8469701
• Product Code: QNR
• UDI-Device Identifier: 07640135140627
• UDI-Public: (01)07640135140627
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2026

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?: No
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 02/16/2026; 03/20/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/27/2026; 04/08/2026
• 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; Required Intervention
• Patient Sex: Unknown