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

Model Number 201-90411

Device Problems Infusion or Flow Problem (2964); Insufficient Information (3190)

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

Event Date 07/19/2023

Event Type  malfunction  

Manufacturer Narrative

A1-4 - patient information was requested but not yet provided.D4 - serial number requested but not provided.Related regulatory reference report mfr # 3003306248-2023-05029.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that there was an equipment failure during centrimag implant.The console alarmed indicating that the motor was disconnect and with flow alarms.The motor and console were switched to backup and the equipment resumed normal operation.There was no patient impact.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of a motor disconnect alarm and flow alarms were not confirmed.The centrimag console (b)(6) was not returned for analysis, and no log files were associated with the reported event.Questions regarding the return status of the centrimag equipment were asked multiple times and no responses were received.This event will be reopened with further analysis if the centrimag equipment returns.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for the centrimag console, serial number(b)(6) , showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.M) provides information regarding emergency/troubleshooting in section 10.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.M) section 12.1 entitled "appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including motor-related and flow-related alarms, 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 centrimag console was evaluated due to the reported event of motor- and flow-related alarms.A log file was extracted from the returned centrimag console (serial number (b)(6)) and was reviewed.Motor- and flow-related alarms were observed; however, the cause of this issue was determined to have been related to the centrimag motor, serial number (b)(6), and has been addressed via the motor¿s investigation.The returned centrimag console was functionally tested at the service depot and was found to perform as intended.Atypical events regarding the console were unable to be reproduced, and the serviced and tested console was returned to the customer site after passing all tests per procedure.Review of the device history record for the centrimag console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.M) provides information regarding emergency/troubleshooting in section 10.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.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 17393014
• MDR Text Key: 319959793
• Report Number: 3003306248-2023-05030
• 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: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2024

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: Health Professional
• Device Model Number: 201-90411
• Device Lot Number: 6398773
• 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: 07/19/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 10/04/2023; 01/25/2024
• Supplement Dates FDA Received: 10/05/2023; 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2018
• 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
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 61 KG