MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Model Number 102956

Device Problem Decreased Pump Speed (1500)

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

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

This medwatch is reporting the centrimag motor.The centrimag console is reported under medwatch mfr report # 2916596-2019-00214.The device was returned for investigation.The evaluation is not yet complete.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.The customer communicated that they were unable to increase the speed above 4300 rpms.There were no alarms noted and the patient was stable with 5 lpm flow.The customer exchanged out the centrimag (cmag) motor and console system.The patient tolerated system change without any injury.No additional information was reported.

Manufacturer Narrative

Section h4: additional information.Device evaluation: although the reported event could not be duplicated, damage to the motor cable was confirmed via the evaluation of the returned motor.A root cause for the damage could not be determined.Additionally, damage to the motor cable had potential to contribute to the reported event.Upon the console being powered on, an m2 motor connection error was displayed.When trying to proceed and set a pump speed, another m5 error code was displayed.These failures confirmed the findings of the product performance engineering group during prior analysis.The testing found intermittent resistance in the cable when they flexed the cable at the connector end bend relief.The unit was deemed defective and will now be scrapped.Reports of similar events have been documented and corrective action has been initiated to investigate similar issues.Reports of similar events will continue to be tracked and monitored.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.The reported event and subsequent investigation do not indicate an issue with the manufacture of the product.No further information was provided.The manufacturer is closing the file on the event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8251316
• MDR Text Key: 133360146
• Report Number: 2916596-2019-00203
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 109