MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR; MOTOR, RENTAL

Model Number L102956

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/29/2018

Event Type  malfunction  

Manufacturer Narrative

This medwatch is reporting the cmag motor.The cmag primary console is reported under medwatch mfr report # 2916596-2019-00241.Approximate age of device - the centrimag motor is not a single use device.The approximate age of the device will be provided in the supplemental report when the manufacturer's investigation is completed.The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was started on extracorporeal circulatory support on (b)(6) 2018.It was reported that the centrimag (cmag) console displayed s3 (system alert) and m6 (motor over temp) error codes.The cmag console and motor were swapped out without any issues.No additional information was reported.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of an m6 alarm could not be confirmed through the evaluation of the returned centrimag motor and a root cause could not conclusively be determined through this evaluation; however, damage to the metal locking ring was confirmed through the inspection of the returned motor.The returned centrimag motor was inspected for interior damage and it was observed that there was damage to the metal locking ring.The motor was tested on a mock loop for an extended period of time with the returned console.The motor was tested for two days and no alarms were triggered.The system operated as intended.The metal locking ring was replaced.A full functional checkout was performed and the unit passed all tests.The motor was returned to the rental pool.The centrimag system operating manual states that "the recommended practice whenever there is a 2nd generation centrimag primary 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 backup motor and console to continue patient support".The centrimag motor ifu 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.An incidental finding of locking ring damage was observed during the evaluation of the centrimag motor.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR
• Type of Device: MOTOR, RENTAL
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8255397
• MDR Text Key: 133334831
• Report Number: 2916596-2019-00243
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

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: L102956
• Device Catalogue Number: L102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 03/25/2019
• Supplement Dates FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 MO
• Patient Weight: 4