MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number L102954

Device Problems Loss of Power (1475); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the centrimag console started top produce smoke then had no power.The unit was being sent in for evaluation and possible repair.Reported that no patient was involved.

Manufacturer Narrative

Manufacturer's investigation conclusion: no patient information was provided on initial report because it was reported that there was no patient involved in the event.The reported event of smoke coming from the console was confirmed via the observed burnt component and burnt smell coming from the console.The centrimag primary console (serial #: (b)(4)) was returned to the service depot for analysis.The returned console was evaluated and tested under work order (b)(4).The service depot inspected the unit and found the unit to have a burnt smell.Component damage was found on the main board as well as the motor controller board.No replacement boards are available, and the unit can no longer be supported.Damage to the motor controller board consisting of burn marks on the power switch, u203, and a missing pin on connector p7 was observed.Fuse, f2, on the main board was blown.The root cause for the smoke coming from the console was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8466841
• MDR Text Key: 140418994
• Report Number: 2916596-2019-01434
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140672
• UDI-Public: 07640135140672
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2020

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 Expiration Date: 04/25/2019
• Device Model Number: L102954
• Device Catalogue Number: L102954
• Device Lot Number: IFS102144
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 06/13/2019; 02/10/2020
• Supplement Dates FDA Received: 06/14/2019; 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1