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	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
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 complete.
Event or Problem Description
It was reported that the centrimag console was displaying an f4 alarm.The unit would be returning, and no further info was available from bio-med.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the centrimag console displaying a f4 alarm was confirmed via the downloaded log file; however, it was not reproduced.Data from the reported event date of 01feb2026 in the returned centrimag console log file was reviewed.At 11:56:38, 16:52:24, 18:20:44, 20:01:46, the "flow signal interrupted: f2" alarm intermittently activated due to a sf_flow_low_amplitude sub fault flag.These alarms resulted in flow dropping to 0 lpm.At 16:52:19 and 20:01:43, the "flow below minimum: f3" alarm intermittently activated due to a sf_ifd_flow_below_min sub fault flag.At 16:20:45, 16:52:29, 16:52:42, 16:52:49, 16:53:38, 18:07:20, and 18:07:26, the "flow above maximum: f4" alarm intermittently activated due to a sf_ifd_flow_above_max sub fault flag.The speed was attempted to be changed multiple times.There were no other notable alarms active in the log file.The returned centrimag console, serial (b)(6) was evaluated at the service depot.The system booted up as intended.The console was connected to a test loop along with the returned flow probe and run for several days.During this period, the console functioned as intended with no atypical alarms observed.The console cover was removed and all internals were inspected and found to be unremarkable.The reported issue could not be reproduced.The console was functionally tested and passed all tests.The unit was ready for use and was returned to the customer.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no response was received.A root cause for the reported event was unable to be conclusively determined.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(6)) and the console 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, rev.D 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 2nd generation centrimag system operating manual, rev.D section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including flow alarms, and the appropriate actions to take if the issue does not resolve.The 2nd generation centrimag system operating manual, rev.D 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." the 2nd generation centrimag system operating manual, rev.D section 9.2 "maintenance following each patient use" states to clean the exterior of the console with bactericidal solution by spraying the solution on a cloth and wiping off the unit after disconnecting from ac power.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 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: 24405100
• Report Number: 2916596-2026-00795
• Device Sequence Number: 18574567
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: (01)07640135140702(11)251107
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 04/27/2026

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: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 11127519
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2025
• 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