MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Model Number	102956
Medical Device Problem Codes	Mechanical Problem (1384); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a broken and frozen set screw on the centrimag motor was not confirmed.The centrimag motor, serial (b)(6), was evaluated at the service depot.The motor was visually inspected and was found to be in good condition with no physical damage observed.The motor was connected to a test loop and run for several days.During the observation period the motor functioned as intended with no unintended alarms or problems observed.The customer reported issue of a broken screw on the locking ring was unconfirmed.The motor was tested and passed all functional tests.The motor is ready for use and will be returned to the customer.A root cause for the reported event was unable to be conclusively determined.The device history records were reviewed for the centrimag motor (serial number: (b)(6) and the motor was found to pass all manufacturing and qa specifications.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.The 2nd generation centrimag system operating manual provides information regarding emergencies/troubleshooting in section 9.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.The centrimag motor ifu instructs the user to inspect the centrimag motor, jacket, cable, console connector, and locking mechanism for damage prior to use.If any component is damaged do not use the centrimag motor.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• 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 ; +1(781)852-8207
• MDR Report Key: 25846933
• Report Number: 3003306248-2026-00256
• Device Sequence Number: 16108209
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: (01)07640135140078(11)231114
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2026

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: 102956
• Device Catalogue Number: 102956
• Device Lot Number: 10079171
• Date Returned to Manufacturer: 06/29/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Supplement Date Received by Manufacturer: Not provided; 09/28/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 09/18/2026; 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown