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

Model Number 201-30300

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Related manufacturer reference number:3003306248-2020-05465.It was reported that patient was under extracorporeal membrane oxygenation (ecmo) support with centrimag blood pump.The perfusionist heard an audible alarm (m4) and saw the motor was very hot and making a noise.Then he immediately replaced the pump for the backup controller and motor.Additional information states perfusionist also mentioned a noise when approaching the pump.The motor was making the noise.Patient had no symptoms.The pump was not exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of an m4: motor alarm regarding the console was not confirmed.The centrimag console (serial number (b)(6) ) was not returned for analysis, and no log files were associated with the reported event.The root cause of the reported event was unable to be 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 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, including battery- and motor-related 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
• 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: 10849557
• MDR Text Key: 217151556
• Report Number: 3003306248-2020-05464
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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: 201-30300
• Device Lot Number: L06875
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, OUS