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

Model Number 201-90421

Device Problems Communication or Transmission Problem (2896); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during testing of the primary console a power on test fail alarm occurred.The account rebooted the system but the alarm kept occurring.The account left the system alone for awhile, when they booted up the system a second time a motor disconnected alarm occurred.The account switched to the backup system, however, the alarm still occurred.No further information was provided.

Manufacturer Narrative

Section h4: additional information manufacturer's investigation conclusion: the reported event of a m2 ¿ motor disconnected alarm was confirmed via the log file.The centrimag 2nd generation primary console (serial #: l01769-0010) was returned for analysis in unremarkable condition to mcs zurich.A log file was downloaded from the returned console for review.A review of the downloaded log file showed events spanning approximately 123 days (1(b)(6)2019 ¿(b)(6)2019 per time stamp).On (b)(6)2019 at 08:49, the console was powered on and the logged motor temperature showed values that indicated a motor has been connected to the console.At 09:21, the sub faults ¿sf_lmc_main_mode_disabled¿ and ¿sf_lmc_motor_disconnected¿ occurred and triggered a ¿motor disconnected: m2¿ alarm.The alarm was able to be cleared but activated again.The console was power cycled again at 09:24 and the events occurred once more.The console was connected to mains power supply and powered on.A test motor and loop was connected to the console as well as the returned and associated flow probe.The motor speed was set to 500 rpm and increased up to 5500 rpm.The speed was decreased to 5000 rpm and after 15 minutes of operation, the motor speed suddenly dropped.A ¿set pump speed not reached: m5¿ alarm activated before the motor speed immediately went back up to 5000 rpm.The fault did not reoccur during 5 days of operation.The console¿s housing was opened after 5 days of operation.Dust balls were found inside of the console, and seen on the motor controller pcb, lmcebpx.Freezer spray was used to cool down the components on the motor control pcb.The cables inside of the console were slightly manipulated; however, no fault occurred on the running system.The console operated as intended.The console was switched off and the next day powered on again.The system operated as intended and no alarms were active.This console is a version v1 and are no longer repairable.The console was subsequently scrapped.The root cause for the reported alarm was not conclusively determined through this analysis.The 2nd generation centrimag system operating manual 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 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 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 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 ADULT FLOW PROBE, CAN
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9469267
• MDR Text Key: 171623396
• Report Number: 2916596-2019-05749
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90421
• Device Catalogue Number: 201-90421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1