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

Model Number L102956

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

The motor is not a single use device.Approximate age of the device is will be determined based on the manufacturer date of the device.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that threads on the motor where it attaches to the motor bracket were stripped out.The issue was found during set up of the motor upon receipt by the site.No alarms were reported.There was no patient involved in this event.

Manufacturer Narrative

The motor is not a single use device.Approximate age of the device is will be determined based on the manufacturer date of the device:11 years and 7 months.The reported of the threads of the motor being stripped where the bracket attaches was unable to be confirmed.The returned centrimag motor, serial number (b)(4), was evaluated by technical services and the reported issue could not be confirmed as the motor easily screwed onto multiple brackets.The centrimag motor service process was performed and the motor performed without any issues and passed all tests.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: 8192611
• MDR Text Key: 131487003
• Report Number: 2916596-2018-05785
• 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: 03/08/2019

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: Lay User/Patient
• Device Model Number: L102956
• Device Catalogue Number: L102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1