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

Model Number 102954

Device Problem Insufficient Information (3190)

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

Event Date 11/23/2022

Event Type  malfunction  

Event Description

It was reported that while preparing/setup for a centrimag implant, an s3 alarm condition was noticed.The power cycled the device without resolution.The console with motor was turned on and off with no resolution of the alarm condition.The motor was then exchanged with a motor from another unit, unit turned off and on, with no resolution of alarm condition.Original motor was reattached to the console and the console and motor were removed from service.Related mfr # 3003306248-2022-14522.

Manufacturer Narrative

There was no patient involved in this event.The pma# provided is associated with the device's most recent approval.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

E1: reporter email was not provided.Manufacturer's investigation conclusion: the reported event of an 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 23nov2022, the system was observed to not be in patient use.The log file captured intermittent s3 alarms correlating to the system¿s voltage generation circuitry on 22nov2022 at 23:27, and 23:40, and on 23nov2022 at 01:29, 06:46, 07:52, and 08:04.The alarms occurred while the system was 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)(6)) was evaluated by service depot.The returned console was tested alongside the returned centrimag motor and known working test centrimag equipment.The returned centrimag console was powered on and during the boot up sequence an s3 alarm activated, reproducing the reported event.The console was then power cycled and the s3 alarm did not reactive throughout testing.The smart power supply printed circuit board (sps pcb) was then replaced with a new sps pcb to resolve the issue.After replacing the sps pcb, the console was functionally tested and found to function as intended during testing.The serviced and repaired console was returned to the customer site after passing all tests per procedure.The damaged sps pcb was forwarded to product performance engineering (ppe) for further analysis.Ppe evaluation of the returned sps pcb revealed that the returned pcb 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 reported event was determined to be an issue with the console¿s sps pcb, the root cause of the reported event 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 qa specifications.The centrimag console was shipped to the customer on 06apr2020.The 2nd generation centrimag system operating manual 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 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.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: 15969182
• MDR Text Key: 308247723
• Report Number: 3003306248-2022-14521
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 7640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093832
• 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: 02/28/2023

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 102954
• Device Lot Number: 7452173
• 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: 11/23/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2020
• 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