MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30300

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  malfunction  

Event Description

It was reported the centrimag consoles were connected to the mag monitors, but the console was unable to supply power to the monitors.

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console not being able to properly supply power to the centrimag monitor was confirmed via analysis of the returned centrimag console.The returned centrimag console (serial number: (b)(6) was evaluated at the european distribution center alongside known working test centrimag equipment.During testing, the centrimag console booted up as intended without any issues; however, it was observed that the centrimag monitor would not power on when connected to the console, reproducing the reported event.The console was disassembled to inspect the internal components, and the issue was isolated to the 12v dc/dc printed circuit board (pcb).After replacing the 12v dc/dc pcb, the issue resolved, and a full functional checkout was then performed and the unit passed all steps of the test without any issues.The serviced and repaired unit was returned to the customer site after passing all tests per procedure.The damaged 12v dc/dc pcb was forwarded to product performance engineering (ppe) for further analysis.Ppe evaluation of the returned 12v dc/dc pcb further isolated the issue to a compromised component.Damage to the component would result in the console¿s inability to properly supply power to the centrimag monitor, resulting the monitor not powering on.The data in the downloaded log file did not indicate any issues with the centrimag console.No atypical alarms were observed in the log file.The reported event was determined to be due to a compromised component on the 12v dc/dc pcb; however, the root cause of the damage could not be conclusively determined through this analysis.The device history records were reviewed, and the records revealed that the centrimag console, serial number (b)(6) was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual section 9 ¿ ¿emergencies/troubleshooting¿ provides instructions for operation when there is a need to exchange the main console or motor with a backup console or motor.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 centrimag 2nd gen system operating manual section 4.1.4 ¿ "monitor" states "should the monitor be disconnected or fail; the console may be operated independently with the relevant operational data displayed on the console display.When the monitor is active, control of motor and pump function may be accomplished using either the monitor or the console.If a monitor is unavailable, the pump and motor can be controlled via the console.When operated in this manner, a number of features that can only be accessed via the monitor will not be available.These include the stopwatch function, graphical displays of the pressure, as well as flow and alarm limits¿.The 2nd generation centrimag system operating manual section 11.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), and the appropriate actions to take if the issue does not resolve.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• 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: 18022601
• MDR Text Key: 326747124
• Report Number: 2916596-2023-07663
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 201-30300
• Device Lot Number: 8496742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1