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

Model Number 201-90411

Device Problem Insufficient Information (3190)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a s3 alarm was confirmed via analysis of the log file downloaded from the returned centrimag console and evaluation of the returned console.On the reported event date of (b)(6) 2021, the system was observed to not be in patient use.Intermittent s3 alarms correlating to the system¿s speaker circuity were captured on (b)(6) 2021 at 14:11, 14:14, 14:51, on (b)(6) 2021 at 14:42, and on (b)(6) 2021 at 10:04.The alarms occurred when the system was booted up while connected to wall power.The system was observed to have been manually shut down and restarted each time that the s3 alarm activated; however, upon booting up the s3 alarm reactivated.The alarms were muted within a minute of activating.No other notable alarms were observed in the log file.The returned centrimag console (serial number: (b)(4)) was evaluated at the service depot alongside known working centrimag equipment.Upon booting up the unit, a s3 alarm activated, reproducing the reported event.The smart power supply printed circuit board (sps pcb) was replaced with a new sps pcb and the issue resolved, isolating the reported issue to the sps board.After replacing the sps board, the returned centrimag console was then functionally tested and fully functioned as intended during testing.Preventative maintenance was performed, and the serviced and repaired unit was returned to the customer after passing all tests per procedure.The replaced sps pcb was forwarded to product performance engineering (ppe) for further analysis.The sps pcb was further evaluated by ppe.Inspection of the returned pcb revealed that it was in unremarkable physical condition.The sps pcb was tested alongside known working test centrimag equipment; however, the reported event was unable to be reproduced throughout ppe evaluation.Circuit analysis of the returned pcb did not reveal any issues; therefore, the reported issue could not be isolated to a specific component.Although the root cause of the reported event was narrowed down to an issue with the console¿s sps pcb, the root cause of the reported event could not be conclusively determined through this analysis.The 2nd generation centrimag system operating manual (rev.11) section 10 ¿ ¿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 2nd generation centrimag system operating manual (rev.11) section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including system alarms, and the appropriate actions to take if the issue does not resolve.The device history records were reviewed and the records revealed that the centrimag console, serial number (b)(4), was manufactured in accordance with manufacturing and qa specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that a newly purchased centrimag primary console had a s3 system alarm upon start-up.After two restarts, the error code disappeared.It was recommended to monitor the console and switch to backup if necessary.The s3 alert returned on (b)(6) and a loaner was requested.

Manufacturer Narrative

The centrimag console was manufactured on 07mar2019.Review of the dhr also revealed that the console was serviced on 06nov2020, and the console¿s smart power supply printed circuit board (sps pcb) was replaced with a new board sps pcb.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 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12550787
• MDR Text Key: 278409022
• Report Number: 3003306248-2021-05696
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 7884659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2019
• 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