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 Communication or Transmission Problem (2896); Unexpected Shutdown (4019)

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

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the console was switched on and prepared for a potential patient.After a self-test was performed, it was discovered that the cable that connects the console and mag monitor was disconnected.The cable was connected; however, during connection, the console shut down.It was not possible to restart the console.The console and mag monitor were removed from use.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag 2nd generation primary console (serial number: (b)(6)) being unable to properly power on was confirmed during testing of the returned product.Upon arrival, a log file was downloaded for review.The log file captured the console being powered on at timestamp 9:27:06 on (b)(6) 2006.The console began to perform the self-test and about twenty seconds later, the console shutdown.The console was not operating a pump during this event.The device was not again powered on successfully until after it was repaired at abbott.Upon connecting the returned console to power, the reported event was reproduced, and the unit could not power on.Further analysis isolated the issue to the unit¿s dc/dc converter pcb, which was replaced.Following the replacement, the unit was functionally tested and found to perform as intended.The serviced and repaired console was returned to the customer after passing all tests per procedure.The extracted 12v dc/dc converter pcb was then forwarded to product performance engineering for further analysis.This board receives input from the power supply pcb, and then outputs a steady voltage to the mag monitor.During evaluation, it was revealed that the converter component itself had been electrically damaged.The electrical short in this component caused the input signal provided by the power supply to drop to ~0v.This signal being shorted impacted the power supply's ability to provide voltage throughout the unit, which ultimately prevented the system from properly powering on.The root cause of the reported event was determined to be electrical damage to the dc/dc converter; however, the cause of this damage could not be conclusively determined through this analysis.The device history records were reviewed for the centrimag 2nd generation console (serial #: (b)(6)) and the console was found to pass all manufacturing and quality assurance (qa) specifications.The 2nd generation centrimag system operating manual (rev.C) section 3 entitled "about the primary console" warns " one back-up console and motor are required in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The back-up console must be connected to the back-up motor, 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 primary console or primary motor experience a malfunction." the 2nd generation centrimag system operating manual (rev.C) section 8 entitled "emergency/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.C) table 14 entitled ¿console alarms & alerts¿ addresses how to interpret and troubleshoot all system alarms.The 2nd generation centrimag system operating manual (rev.C) section 7 "maintenance" states that the battery maintenance procedure needs to be performed every 6 months.If the system requires the battery maintenance procedure to be performed, it will display the alert.Additionally, it mentions to replace the internal rechargeable battery every 2 years.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: 16045678
• MDR Text Key: 308178492
• Report Number: 3003306248-2022-14531
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• 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: 7115039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2019
• 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