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	01/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that an s3 alarm occurred during a patient transport within a hospital.The customer stated that while transporting a centrimag venovenous extracorporeal membrane oxygenation (vv-ecmo) patient, the centrimag console was plugged into a battery backup/power strip device.The s3 alarm did not resolve when they plugged the battery backup device into a hospital emergency outlet.The customer was advised to discontinue the use of the power strip and to switch to another centrimag console and motor that was plugged directly into a red hospital ac power outlet.The customer stated that they did not want to switch to another device at this time as the patient was considered a do not resuscitate (dnr) and that somehow switching to another device would be a problem.Several hour later the customer switched to another centrimag console yet continued to use the battery backup/power strip device and the 2nd centrimag system also displayed an s3 alarm.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• 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: 24217901
• Report Number: 3003306248-2026-00014
• Device Sequence Number: 8392091
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: (01)07640135140702(11)191218
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: 12/31/2019
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6252024
• 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: 01/11/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2017
• 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: Male