MAUDE Adverse Event Report: THORATEC CORPORATION PRIM CONS 1ST GEN, STANDALONE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number	201-30100
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
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 during the technical inspection for possible release, it was detected that the equipment was discontinued equipment.It was tested on the power supply and did not turn on.The product would be sent for destruction.
Additional Manufacturer Narrative
B5 narrative information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was communicated on 03feb2025 that the equipment did not involve any patient.The equipment was repaired at the service center in brazil, and it would be returned for repair in the united states.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the centrimag console not powering on was not confirmed.The centrimag console (serial number (b)(6) was not returned for analysis.Available information for this event indicates that no patients were associated with the event, and that the unit was sent for destruction, as the 1st generation centrimag consoles are obsolete and cannot be repaired.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for the centrimag primary console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The centrimag primary console operating manual (rev.08, section 10 ¿emergency/troubleshooting¿) states: "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 to continue patient support.Do not exchange individual motors or individual consoles during patient support." no further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was further communicated on 17jun2025 that the equipment was sent for destruction.The product was confirmed to be a console.

• Brand Name: PRIM CONS 1ST GEN, STANDALONE
• 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 CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 20619560
• Report Number: 2916596-2024-07124
• Device Sequence Number: 18361455
• Product Code: DWA
• UDI-Device Identifier: 07640135140672
• UDI-Public: (01)07640135140672(11)120401
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2025

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: Other
• Device Model Number: 201-30100
• Device Catalogue Number: 201-30100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 02/03/2025; 06/17/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 02/23/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2012
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown