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

Model Number	102956
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that an s3 alarm was reported on the centrimag main unit.In addition, battery maintenance was unable to be performed despite troubleshooting attempts.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of an s3 alert was unable to be confirmed.The centrimag motor (serial number: unknown) was not returned for analysis.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The root cause for the reported event was unable to be conclusively determined through this analysis.Device history records could not be reviewed due to the serial number of the centrimag motor being unknown.The current revision of the instructions for use (ifu) and operating manual can be found on the eifu page of the abbott website.The 2nd generation centrimag system operating manual section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including system alarms, and the appropriate actions to take if the issue does not resolve.The 2nd generation centrimag system operating manual section 10 ¿ ¿emergencies/troubleshooting¿ provides instructions for operation when there is a need to exchange the main console or motor with a backup console or motor.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 2nd generation centrimag system operating manual section 4 ¿ "warnings & precautions" states that one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedimag pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." 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 ; 7818528207
• MDR Report Key: 24560057
• Report Number: 3003306248-2026-00134
• Device Sequence Number: 21187727
• Product Code: KFM
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 06/23/2026

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
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 03/11/2026; 06/17/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/16/2026; 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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