MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, OUS; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problem Mechanical Problem (1384)

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

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the centrimage motor had an issue with the thumb screw.The motor was exchanged.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of damage to the set screw was confirmed via evaluation of the returned centrimag motor (serial number: (b)(6) ), as the set screw was observed to be damaged upon arrival.The damaged metal locking mechanism was replaced with a new locking mechanism.After replacing the locking mechanism, the unit was then tested with known working test centrimag equipment and the motor functioned as intended without any issues.A full functional checkout was performed, and the unit passed all tests without any issues.The serviced and tested unit was returned to the customer site after passing all tests per procedure.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 motor, serial number (b)(6) , was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual section 10 ¿ ¿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.Centrimag motor instructions for use instructs the user to inspect the centrimag motor, cable, console connector, and locking mechanism for any damage prior to use.If any component is damaged, do not use the centrimag motor.This document states that if the unit fails to operate according to the motor specifications or a console diagnostic error indicates a centrimag motor malfunction, it should be returned.Additionally, this document instructs the user to always have a spare centrimag motor and back-up equipment available.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, OUS
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 11807779
• MDR Text Key: 251243253
• Report Number: 3003306248-2021-01108
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• 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: 07/29/2021

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: No Information
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1