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

Model Number 201-10002

Device Problem Use of Device Problem (1670)

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

Event Date 03/08/2021

Event Type  malfunction  

Event Description

It was reported that during a training the perfusion team received an m4 alarm on a centrimag motor.The consoles were switched but the alarm persisted and the motor was put aside.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a m4 alarm was not confirmed as the alarm was not reproduced during testing of the returned centrimag motor (serial number: (b)(6), and no log files were submitted for review.However, damage to the motor that may have contributed to the reported event was confirmed.The returned centrimag motor was evaluated at the european distribution center alongside known working centrimag equipment; however, a m2 and m3 alarm activated after connecting the motor to the console, indicating that the motor was unable to be recognized by the console.The resistance of the wires in the motor cable were measured and it was revealed that two of the motor¿s bearing phase wires were electrically open.The damage to the wires would prevent the motor from functioning properly and may have contributed to the reported event.It was advised to scrap the motor after approval from customer service.The reported event appears to be due to wire fatigue in the motor¿s cable; however, the root cause of the damage to the cable could not be conclusively determined through this analysis.Incidental findings: the screw on the motor cable connector was observed to be loose, damage to motor cable cap.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.The 2nd generation centrimag system operating manual section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including motor alarms, and the appropriate actions to take if the issue does not resolve.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.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 qa specifications.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: 11591120
• MDR Text Key: 253824929
• Report Number: 3003306248-2021-01079
• 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: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-10002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1