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

Model Number 201-90411

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Patient information was requested, but not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the centrimag (cmag) primary console was blowing fuses.The fuses were changed out, but as soon as the unit was turned back on the fuses blew out again.The console was sent for repair.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console blowing fuses upon being powered on was confirmed.The returned centrimag 2nd gen.Primary console (serial number: (b)(6) was tested on 23jan2020.A log file was downloaded from the console and was reviewed.Potential damage to the power supply pcb was observed throughout the log file, as the console¿s battery was in use and was not being charged throughout the observed data.Upon turning the console on, the console was not charging the battery when connected to power, and the console only operated on battery power.A test battery was placed into the returned console, and the returned battery was placed into a test console in order to charge.Two new fuses were placed into the returned console, which blew upon power being applied to the system.A new 24v power supply pcb was installed, as well as two new fuses.After this, the console was functionally tested and was found to perform as intended.The console was switched on and off 20 times while connected to ac power and no atypical events occurred after the power supply pcb had been replaced.Faulty power supply pcbs can cause higher voltages and currents to flow through the system which may damage components.The console was reprocessed with the returned flow probe and passed all required testing.The repaired unit was returned to the customer site.The root cause of the reported event was a defective 24v power supply pcb within the centrimag console.The labeling 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."2nd generation centrimag primary console alarm/alert strategy," lists all alarm conditions and what actions to take when they occur, including alarms related to battery usage and low battery conditions.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
• MDR Report Key: 9207764
• MDR Text Key: 163143690
• Report Number: 2916596-2019-04727
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1