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

Model Number 201-90411

Device Problems Failure to Power Up (1476); Electrical Power Problem (2925)

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

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that a backup centrimag console experienced a s1 power on test failure alarm.The console was rebooted but the alarm persisted.Upon rebooting again, the alarm resolved and the console booted normally.The console was pulled from service.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console not passing the self-test was confirmed via analysis of the returned console.The returned centrimag console was evaluated by service depot and tested alongside known working test centrimag equipment for several days.During testing, the console was power cycled several times and the reported event of an s1 alarm activating during the initial boot up sequence was reproduced once.Further testing isolated the issue to the console¿s power switch assembly.The damaged power switch assembly was replaced with a new assembly and the issue resolved.After replacing the switch assembly, the console was functionally tested and found to function as intended during testing.The serviced and repaired unit was returned to the customer site after passing all tests per procedure.A log file was downloaded from the returned centrimag console.Prior to the reported event date of 20sep2022, the system was observed to be operating the motor at the set speed without any issues.On 18sep2022 at 08:04 and at 08:05, a s1 alarm activated correlating to a power button related sub-fault.The alarms appeared to be intermittent and occurred following the initial boot up sequence of the centrimag console.The console was powered on and off several other times throughout the log file, however, the s1 alarm did not activate at those times.No other notable alarms were observed in the log file.The reported event of the centrimag console not passing the self-test was determined to be due to a damaged power switch assembly; 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, was manufactured in accordance with manufacturing and qa specifications.The centrimag console was shipped to the customer on 09jul2018.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 ¿ 2nd generation centrimag primary console alarms and alerts" cover all alarms (auditory and visual), including system related 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: 15565759
• MDR Text Key: 306433951
• Report Number: 3003306248-2022-12518
• 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: 12/02/2022

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: 06/30/2020
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6517363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2018
• 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