MAUDE Adverse Event Report: THORATEC CORPORATION; 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	02/20/2026
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 the centrimag motor was sent to the customer and they tried to exchange the centrimag motor on (b)(6) 2026.The centrimag console experienced a m5 error message, which alluded to a centrimag pump issue.The centrimag console was turned off and turned back on, which cleared the alarm.After that, the centrimag console received a m2 pump not connected alarm which blocked the rpms from being adjusted so they would not increase.Then the customer connected another centrimag pump head to the centrimag console and did not have any issues.The customer was unsure if the pins were bent inside the centrimag pump connection.The product will be returned for evaluation and repair.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of motor-related alarms was not confirmed.The returned centrimag motor (serial number (b)(6)) was functionally tested alongside a mock loop and known working test equipment at the service depot, and the motor was found to function as intended.Atypical events and issues with the motor were unable to be reproduced throughout all testing, even when the motor¿s cable was manipulated.The serviced and tested motor was returned to the customer site after passing all tests per procedure.No log files were provided.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for centrimag motor, 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 motor-related alarms, as well as appropriate operator response to these events.Centrimag motor ifu instructs the user to inspect the centrimag motor, cable, console connector, and locking mechanism for any damage prior to use.If any component is damaged, do not use the centrimag motor.This document states that if the unit does not operate according to the motor specifications or a console diagnostic error indicates a centrimag motor malfunction, it should be returned.Additionally, this document instructs the user to always have a spare centrimag motor and back-up equipment available.No further information was provided.The manufacturer is closing the file on this event.
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
The product was removed from use.The vad coordinator suggested that there might be possibility that the pins were bent and this was a suspected reason that the centrimag motor was malfunctioning.

• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• 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: 24561138
• Report Number: 3003306248-2026-00140
• Device Sequence Number: 8860677
• Product Code: KFM
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2026

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?: 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: 02/20/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 04/09/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/03/2026; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2010
• 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