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

Model Number 201-30300

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred at (b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Related manufacturer reference number: 3003306248-2020-00089.It was reported that the patient was connected to centrimag as a ecmo therapy.Suddenly the screen of the console turned off and the flow probe did not register information about the flow, but the motor was still working.No product will be returned, the patient was still under ecmo therapy at time of reported event.Distributor loaned two other motors.The event resolved with the use of the backup motor and console.The backup motor was used, and changed motors as soon as possible.Additional information received on 08oct2020 stated that the motors were affected by the fsca 2019-08, which states that the customers have experienced unexpected console screen blanking, low flow or no flow, and motor behavior including noise, vibration and heating at a rate of (b)(4).Our investigation has identified certain centrimag motors with serial numbers have an increased susceptibility to electromagnetic interference (emi).The issue can be mitigated through re-calibration of the motor.The centrimag¿ 2nd generation console will be returned.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the console screen suddenly turning off and the screen showing a blank flow was not confirmed as the centrimag console (serial number: (b)(6)) was not returned for analysis, and no log files were submitted for review.Additional information provided stated that the console would not be returned for analysis and that no log files are available to be submitted for review.It was also communicated that when the hospital was lent two centrimag motors to troubleshoot the reported event, the issue reoccurred on both motors; therefore, the reported event appears to be a console related issue.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the centrimag console, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 8 ¿ ¿emergencies/troubleshooting¿ provides instructions for operation when there is a need to exchange the main console or motor with a backup console or motor.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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer report numbers: mfr # 3003306248-2020-00091, mfr # 3003306248-2020-00089, mfr # 3003306248-2020-00092.It was reported that the issue occurred again on the backup motor and backup console.When the hospital was lent two additional centrimag motors to troubleshoot the reported event, the issue reoccurred again on both lent motors.

• 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: 10715938
• MDR Text Key: 214804777
• Report Number: 3003306248-2020-00088
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• 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: L06473
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, OUS.