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	Mechanical Problem (1384); Noise, Audible (3273)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a: patient information was not provided.Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.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 through medwatch report # mw5176465 that the assistant mechanical circulatory support (mcs) coordinator reported a new squeaking sound coming from the centrifugal pump (cp).They sent a short clip of the centrifugal pump with the high-pitched noise.They also sent a picture of the gallery view with the patient parameters shown.The clinical specialist called for the details.There were some changes in patient parameters, which suggested a circuit change out was needed.They changed the circuit to a centrimag pump.They almost discovered a clot in the circuit and sent a photo of it.The patient parameters on the centrimag screen seemed to have been normal for the time being.A biohazard kit was delivered.It was reported that the same patient developed a clot while on the previous circuit with rotoflow before switching to vitalflow.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported noise and suspected clot were unable to be confirmed through this evaluation as no images or product were submitted.A specific cause for the reported events could not be conclusively determined through this evaluation.No additional information was available, and the centrimag blood pump was not returned for evaluation.The lot number was not reported.The centrimag blood pump instructions for use (ifu) is currently available and lists venous thromboembolism and arterial non-cns (non-central nervous system) thromboembolism as adverse events that may be associated with the use of the centrimag blood pump.The ifu 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 caution #8: ensure the pump is properly locked into the motor per the instructions for use supplied with the motor.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 ¿pump setup and operation¿ provides instructions for how to mount the blood pump on the motor.The following instructions are provided: to mount the pump on the motor, remove the pump from the inner tray and insert the pump into the motor receptacle.Place the bottom of the pump into the motor receptacle with the outlet port positioned in the large groove.Match the grooves on the periphery of the pump with the fittings on the motor receptacle.Rotate the pump counterclockwise until the pump locks securely into place.Thread the retaining screw clockwise to secure in place.The pump must be fully seated into the receptacle to function properly.The section titled ¿emergency backup equipment¿ states that a backup sterile pump and supplies to prime must be available.The current revisions of the instructions for use (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.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of a suspected clot was unable to be confirmed through this evaluation as no images or product were submitted.A specific cause for the reported events could not be conclusively determined through this evaluation.No additional information was available, and the centrimag blood pump was not returned for evaluation.The lot number was not reported.The centrimag blood pump instructions for use (ifu) (rev.C) is currently available and lists venous thromboembolism and arterial non-cns (non-central nervous system) thromboembolism as adverse events that may be associated with the use of the centrimag blood pump.The ifu 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 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 backup equipment¿ states that a backup sterile pump and supplies to prime must be available.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 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: 23469205
• Report Number: 2916596-2025-06964
• Device Sequence Number: 8890974
• Product Code: QNR
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 11/17/2025; 01/28/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/09/2025; 01/30/2026
• 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: Required Intervention
• Patient Sex: Unknown