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 Problems Electrical /Electronic Property Problem (1198); Use of Device Problem (1670)

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

Event Date 06/14/2023

Event Type  malfunction  

Event Description

It was reported that after exchanging the battery, the device was turned on and produced an error.

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 displaying an error upon being powered on was confirmed.Log files were extracted from the returned centrimag console (serial number (b)(6)) at the european distribution center (edc) and at the product performance engineering (ppe) department.The console was not observed to have been in use within the timeframe of the reported event date (jun2023).Throughout data recorded in the logs on 14sep2022, 14mar2023, and 27jul2023, s1 alarms were intermittently observed when the console was powered on, indicating that the console was not passing its power-on self-test.These alarms correlated to sub-faults indicating that part of the console¿s communication circuitry was not functioning as intended, making the motor control printed circuit board (pcb) unable to communicate with the interface display (ifd) pcb and the flow pcb.The returned centrimag console was functionally tested at the edc and at the ppe department.S1 alarms were reproduced upon powering the console on.A known working test motor control pcb was placed within the console, resolving the alarm.The console was functionally tested and was found to perform as intended with a test pcb, operating a motor and mock loop at various speeds for extended periods of time.The original motor control pcb was placed within a known working test fixture, and the s1 alarm reoccurred, further narrowing the cause of the issue down to the motor control pcb.The motor control pcb was electrically measured, and one of the pcb¿s components associated with the sub-faults observed in the log file was observed to not be properly communicating with the pcb¿¿¿s microprocessor.The component responsible for the motor control pcb¿s communication with the ifd pcb and the flow pcb was replaced with a new component; however, one of the component¿s solder pads became damaged during the resoldering process.Further isolation of the root cause was not possible.The root cause of the damage to the motor control pcb, causing the alarms to occur, was unable to be conclusively determined through this analysis.Review of the device history record for 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 section 3 "warnings and 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 (¿table 15: console maintenance schedule¿) instructs users to have the centrimag console¿s internal battery replaced every two years.Users are instructed to contact abbott for assistance in replacing the battery, as users may not replace the internal battery without proper training or assistance.The 2nd generation centrimag system operating manual section 11.1-"appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including s1 alarms, 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: 17260448
• MDR Text Key: 318615707
• Report Number: 3003306248-2023-01959
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 09/28/2023

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 Model Number: 201-90401
• Device Lot Number: 6722318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2018
• 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