MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number	102953
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a: patient initials not yet available.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient was placed on centrimag support in the catheterization laboratory.Upon initiation, a massive blood transfusion was started.Clot formation occurred within the circuit, resulting in a low flow alarm.The perfusionist observed cessation of flow and replaced the circuit.The original circuit had clotted off.The manager requested an explant kit for the motor and console to be tested for safety evaluation.The cannulas were flushed by the surgeon; however, no flow was observed, so the circuit change.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported circuit clotting and low flow alarms could not be confirmed as no product, images, or log files were provided.A specific cause for the reported events could not be conclusively determined through this evaluation, and a direct correlation with the centrimag blood pump could not be conclusively established.Multiple requests for additional information regarding this event were submitted to the account; however, no response has been received at this time.The centrimag pump was not returned for evaluation.The centrimag blood pump instructions for use (ifu) is currently available.The ifu lists venous thromboembolism and arterial non-cns (non-central nervous system) thromboembolism as adverse events that may be associated with the centrimag circulatory support system under ¿adverse events.¿ the ifu also provides the following warnings and cautions: ifu warning #7: it is intended that systemic anticoagulation be utilized while this device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Ifu warning #10: frequent patient and device monitoring is recommended.Ifu warning #12: do not operate the pump in the absence of forward flow.The temperature within the pump will rise and increased cellular damage and clotting may result.Ifu warning #15: monitor the patient¿s hemodynamics and the console flow display to ensure adequate blood volume for the inlet cannula position, pump rpm, and desired flow.Increase the pump rpm in small increments to minimize the risk of exceeding the available blood volume and causing inlet cannula obstruction, suction, outgassing, and/or cavitation.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #6: attach tubing to the pump in such a manner as to prevent kinks or restrictions that may alter flow or cause regions of stasis or turbulence.Attach in a manner that does not bend or fracture the tubing connectors or ports.Advance the tubing beyond the second barb point of the pump connectors.Ifu caution #9: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.The section titled ¿emergency back-up equipment¿ states that a backup sterile pump and supplies to prime must be available.The ifu also contains a section titled emergency pump replacement.The centrimag operation manual 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 instructions for use (ifu) and operation manual can also be found on the electronic ifu (eifu) page of the abbott website.Review of the device history record (dhr) for the centrimag blood pump, lot number 10879686/l08366-la3, revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23466755
• Report Number: 3003306248-2025-00303
• Device Sequence Number: 8894077
• Product Code: KFM
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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 Model Number: 102953
• Device Catalogue Number: 102953
• Device Lot Number: 10879686
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2025
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic