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

Model Number 102956

Device Problem Pumping Stopped (1503)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

The patient information was not provided.Approximate age of device - the motor is not a single use device.The device was returned for analysis.Evaluation is not complete.No additional information was provided.A supplemental report will be submitted when the device analysis is completed.

Event Description

The patient was being supported with an extracorporeal circulatory support pump.It was reported that the motor was producing an m4 motor failed error when connected to the console.Additional information was requested but was not provided.

Manufacturer Narrative

Approximate age of device - 7 years, 4 months.Investigation conclusion: the reported event was confirmed through the evaluation of the returned centrimag motor; however, a root cause could not be determined.The returned centrimag motor (serial number (b)(6) was evaluated and tested by tech service under work order # (b)(4).An open connection in the current bearing phase a2 connection was found.Resistance was intermittent when the cable was flexed at the connector end bend relief.Additionally, damage to the metal locking ring was observed.The motor couldn't be repaired and was returned to the customer.Due to no longer being suitable for human use, not for human use and defective labels were placed on the motor.It was recommended that the unit be scrapped from customer inventory.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• 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: 8175186
• MDR Text Key: 130990770
• Report Number: 2916596-2018-05528
• Device Sequence Number: 1
• Product Code: KFM
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2021
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1