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

Model Number 102956

Device Problem Pumping Stopped (1503)

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

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

The motor is a single use device.The device is expected to be returned for analysis.It has not yet been received.No further information is available at this time.A supplemental report will be submitted with the manufacture investigation is completed.

Event Description

The patient was implanted with an extracorporeal circulatory support pump.It was reported that after attaching the motor to the centrimag primary console, the console alarmed with m3, motor stopped error.The motor will be returned for evaluation.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a motor error could not be confirmed through this evaluation as no motor errors were reproduced during the analysis of the returned centrimag motor and no console log file data from the time of the reported event is available.The centrimag motor, serial number (b)(4), was returned and evaluate.The reported event was not confirmed and could not be duplicated during testing.The system did not display any error codes or messages at any point.The unit and pump ran smoothly at all speeds.The motor cable was inspected and no issues were found.A full functional checkout was performed and the unit passed all tests.The returned device was found to function as intended.As a result, the root cause for the reported event could not be conclusively determined nor correlated to a device related issue.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.The centrimag motor was returned to the customer site.

• 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: 7979933
• MDR Text Key: 126100547
• Report Number: 2916596-2018-04452
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2019
• Patient Sequence Number: 1