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

Model Number	102953
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Hemodynamic instability (4868)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the flow had to be set "quite high" in order to get it to flow at all, then come back down a bit.A few hours later in cardiovascular, flows were lost again and had to switch to another circuit.There was some clotting in the venous cannula.It was noted there was also a correlation between hemodynamics and the event.The centrimag console was exchanged.
Additional Manufacturer Narrative
A4 - patient weight was not provided by customer.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: clotting was unable to be confirmed as the device was not returned for evaluation, and no photos were submitted.A direct correlation between the reported events and the centrimag blood pump could not be conclusively determined through this evaluation.It was reported that flow initially had to be set quite high in order to get any flow and was then able to come back down a bit.Flow was lost again completely a few hour later, and the centrimag circuit was exchanged.There was some clotting in the venous cannula.There was noted to be a correlation in hemodynamics.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.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) (rev.C) 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 contains the following additional 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 #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.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 current revisions of the instructions for use (ifu) and operation manual can also be found on the electronic ifu 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 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23547846
• Report Number: 3003306248-2025-00321
• Device Sequence Number: 15896389
• Product Code: QNR
• UDI-Device Identifier: 07640135140627
• UDI-Public: (01)07640135140627
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: 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: 10/21/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/29/2025
• 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: Required Intervention
• Patient Sex: Unknown