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

Model Number 102956

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

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 further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient is supported by an extracorporeal circulatory support device.It was reported that the primary console generated an s3 error code that the bio-med engineer could not clear after using the acknowledge button.The motor and console was exchanged.The s3 error code did not affect pump speed or patient support.

Manufacturer Narrative

Additional information: the centrimag motor is not a single use device.Years, 9 months investigation conclusion: the returned centrimag motor (serial number (b)(4) was evaluated and tested by tech service under work order # (b)(4).The reported complaint could not be verified during their testing.The motor was tested along with its related centrimag 2nd gen primary console (serial number (b)(4), evaluated under (b)(4) and flow probe (serial number (b)(4), evaluated under (b)(4).The system was operated at different speed settings without any error codes or other issues being reproduced.However, the motor's locking feature was noted to be defective.The locking feature's set screw was noted to be bent.The root cause of the damaged screw could not be conclusively determined.However, the damage could have prevented a pump from being properly secured to the motor, which can result in high motor temperatures during operation.The damaged locking mechanism was replaced with a new one.Inspection of the motor's cable did not reveal any issues.The motor was tested per the centrimag motor service process and the unit passed all tests.The returned motor functioned as designed.As a result, the root cause of the reported events could not be conclusively determined.The tested motor was returned to the customer site.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this 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: 8114226
• MDR Text Key: 128743784
• Report Number: 2916596-2018-05109
• Device Sequence Number: 1
• Product Code: DWA
• 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: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• 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: 11/21/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Patient Sequence Number: 1