MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	102954
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: device serial number and lot number were not provided, and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information provided.A supplemental report will be submitted once the manufacturer investigation is complete.
Event or Problem Description
It was reported that the centrimag motor failed on a patient.
Additional Manufacturer Narrative
Corrected data: section d5: operator of device corrected.No further information provided.A supplemental report will be submitted once the manufacturer investigation is complete.
Event or Problem Description
The patient had become hypotensive and needed to be treated while the perfusion team switched to a backup motor.The patient was removed from extracorporeal membrane oxygenation (ecmo) support a few days later and was transferred to the critical care unit (ccu).The patient passed away a few days later.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the centrimag system unexpectedly stopping was not able to be confirmed.The centrimag console (serial number unknown) was not returned for analysis, and no log files were provided.Attempts were made to obtain additional event information, but no response was received.The root cause of the reported event could not be determined via this investigation.The device history records were unable to be reviewed due to the serial number of the console being unknown.The 2nd generation centrimag system operating manual section 3 "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 11.1-"appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including s3, m5, m4, and flow-related alarms, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 1ST 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 22167876
• Report Number: 3003306248-2025-00182
• Device Sequence Number: 7829752
• Product Code: DWA
• UDI-Device Identifier: 07640135140672
• UDI-Public: (01)07640135140672
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093832
• 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): 10/23/2025

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: 102954
• Device Catalogue Number: 102954
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 10/06/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/19/2025; 10/23/2025
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 97 KG