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

Model Number 102956

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device: the motor is not a single use device.The approximate age of the device is 7 years and 3 months, calculated from the date of manufacture.The device was returned for investigation.The evaluation is not yet complete.The centrimag motor was manufactured october 1, 2011.No additional information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the centrimag motor was overheating.The unit will be returned to the manufacturer for repair.At the time of the event, there was no patient involvement.No further information is available.

Manufacturer Narrative

Section h1: corrected from malfunction to serious injury.Manufacturer's investigation conclusion: the reported event of the centrimag motor overheating could not be confirmed nor reproduced during testing of the returned centrimag motor (serial number (b)(4).The returned motor was evaluated and tested by the service depot under work order # (b)(4).The reported complaint could not be verified nor reproduced during testing.The returned motor was operated with a test system for an extended period of time without any atypical alarms or temperatures being reproduced.The motor's cable was inspected and no issues were observed.Full functional checkout was performed per the centrimag motor service process and the motor passed all tests.The returned motor was found to function as designed.As a result, the root cause of the reported event 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: 8309211
• MDR Text Key: 135133014
• Report Number: 2916596-2019-00403
• 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: 04/26/2019

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: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• 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: 01/22/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 04/22/2019
• Supplement Dates FDA Received: 04/26/2019
• Patient Sequence Number: 1