MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	201-90411
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during priming the console had an s3 alarm.The motor and console were removed from use.
Additional Manufacturer Narrative
Section d4 correction: no device expiration date.Manufacturer's investigation conclusion: the reported event of an s3: system fault alarm was confirmed via the log file.The log file captured two s3: system fault alarms on 17feb2026, and the system was not observed to have been in patient use at these times.The alarms correlated to sub-faults related to the fan speed, and the system was observed to have been manually shut down shortly after each alarm.No other notable events were observed.The returned centrimag console (serial number (b)(6) was functionally tested at the service depot and was found to appear and perform as intended.Atypical alarms were unable to be reproduced throughout testing.The serviced and tested console was returned to the customer site after passing all tests per procedure, and the root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for centrimag 2nd gen.Primary console, serial number (b)(6) showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4 "warnings and precautions" warns "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 pedivas blood 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." the 2nd generation centrimag system operating manual section 12.1-"appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including s3 alarms, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• Manufacturer Contact: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24524190
• Report Number: 2916596-2026-01071
• Device Sequence Number: 9704194
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: (01)07640135140702(11)180626
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K131179
• 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): 05/06/2026

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 Expiration Date: 10/31/2020
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6695865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 05/01/2026; 05/06/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/06/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2018
• 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