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

Model Number L102956

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

There was no patient involvement in this event.The motor has been received for analysis but the evaluation is not complete.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that during priming of a circuit, the motor overheated.The motor was switched to the backup motor.No alarms were observed during this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the returned centrimag motor was evaluated and tested by the service depot.The reported complaint was not verified nor duplicated during their evaluation.The motor ran for an extended period of time, including overnight, with a test console and flow probe.The motor did not overheat at any point and no alarms or any other issues were observed at any point.The motor always performed as intended.A full functional checkout was performed per the centrimag motor service process and the unit passed all tests.The returned motor was found to function as intended.As a result, the reported event could not be confirmed and the root cause of the event could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.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: 8912933
• MDR Text Key: 154961514
• Report Number: 2916596-2019-03891
• 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: 10/02/2019

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: L102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1