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 Failure to Power Up (1476)

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

Event Date 07/05/2023

Event Type  malfunction  

Event Description

It was reported that after connection of power cord, the primary console was still showing power supply only from the internal battery.The power cord was exchanged, a different wall socket was tried and the issue did not resolve.The centrimag primary console was exchanged and returned to edc.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console only operating on battery power while being unable to accept voltage from the wall socket was confirmed.A log file was extracted from the returned centrimag console (serial number (b)(6)) and was reviewed.The console was not observed to be in patient use on the reported event date, 05jul2023.The console was observed to be powered on and off several times on this date, and the console always operated on battery power, indicated by the b6: on battery alarms.The returned centrimag console was received and tested at the european distribution center.Throughout testing, the console would only operate on battery power and would not accept voltage from the wall socket, consistent with the data observed in the log file.The unit was troubleshot, and the issue resolved upon replacing the unit¿s 24-volt power supply.Then, the unit functioned as intended and was returned to the customer site after passing all tests per procedure.The centrimag console¿s original 24-volt power supply was forwarded to the product performance engineering department for further analysis, where it was determined that the power supply was electrically damaged across various components, including its connectors to the main voltage line and to its connections to other parts of the system.As a result, the power supply was unable to properly receive and supply voltage from the wall socket while in use within a known working test console fixture, and the fixture operated a mock loop while on battery power.The root cause of the reported event was determined to be damage to the console¿s 24-volt power supply; however, the root cause of how the power supply became damaged was unable to be conclusively determined.Review of the device history record for the centrimag console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual 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.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 17384494
• MDR Text Key: 319976413
• Report Number: 3003306248-2023-01966
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: MU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 201-90401
• Device Lot Number: 7053937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2019
• 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