MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90401

Device Problem No Display/Image (1183)

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

Event Date 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the console display did not turn on when preventative maintenance was to be performed.The console emitted its normal audible alerts when the console was turned on, but the display did not.The console was exchanged.

Manufacturer Narrative

Section e: this event occurred at (b)(6).Manufacturer's investigation conclusion: the reported event of the centrimag 2nd generation primary console not turning on when preventative maintenance was performed was not confirmed.The centrimag 2nd generation primary console (serial number l06923-0003) was not returned for analysis.Additionally, there were no photos, log files, or any other supporting documentation submitted that would indicate an issue with the console.If the console returns for analysis, the file will be reopened to address the return.Provided information stated that the console was removed to send to the factory for revision, a replacement console was sent to the client, and the console was exchanged, and they are in the internal procedures for importation.Additionally, the follow-up for the return status of the returning console is being forwarded to foreign trade team to obtain information about the shipment.If the product is received the investigation will be re-opened.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(6)) and the console was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.L) section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual (rev.L) section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary 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 backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual (rev.L) has an emergency/troubleshooting section for the 2nd generation console.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.L) section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag 2nd generation primary console not turning on when preventative maintenance was performed was confirmed via visual analysis and testing of the returned unit.The centrimag 2nd generation primary console (serial number (b)(6)) was returned to the service depot in unremarkable physical condition and a log file was downloaded.The log file contained events spanning approximately 10 days (19jun2022, 20jun2022, 11jul2022, 09aug2022, 18aug2022, 07sep2022, 08sep2022, 07oct2022, 12oct2022, and 17jan2023 per the timestamp).There were no atypical alarms active in the log file.During the service depot evaluation, the returned console was connected to ac power and was switched on.During the bootup sequence, the leds and speakers worked as intended; however, the display did not light up, confirming the reported event.The console was further inspected and the display screen was found to be non-functional.The display screen printed circuit board (pcb) was replaced with known working components and resolved the reported issue.The display pcb was forwarded to product performance engineering (ppe) for further analysis.During ppe testing, the display pcb and screen was visually observed and placed in a known working test fixture.The reported event was confirmed when the system turned on and the display screen did not turn on.No further testing was completed at this time.A manufacturing task was initiated to investigate the issue of the faulty console display.It was determined that there are controls and instructions in place that the issue would have been detected while performing the final test of the console.The device history record (dhr) review provided evidence that the product was functioning correctly when it was sent out to the customer.It can be concluded that this issue could potentially be related to a manufacturing problem; however, the root cause could not be determined.A supplier corrective action request (scar) was initiated to inform the supplier.A risk task was also initiated to address the issue of the faulty condole display from a risk documentation standpoint.The root cause of the reported event could not be conclusively determined through this analysis; however, it could be related to a manufacturing issue.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(6)) and the console was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.L) section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual (rev.L) section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary 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 backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual (rev.L) has an emergency/troubleshooting section for the 2nd generation console.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.L) section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
• 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: 15674094
• MDR Text Key: 306749562
• Report Number: 3003306248-2022-14503
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2023

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 Model Number: 201-90401
• Device Lot Number: 7753556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 11/18/2022; 02/28/2023
• Supplement Dates FDA Received: 11/22/2022; 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2020
• 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