MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2019

Event Type  Injury  

Manufacturer Narrative

The age of the device is unknown.It is unknown whether the patient remains ongoing with the device.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) and a centrimag extracorporeal circulatory support pump more than a year ago; the date is unknown.It was reported that the centrimag motor and primary console were extremely hot to the touch.The motor and console were exchanged.Additional information was requested, but not provided.

Manufacturer Narrative

The centrimag console used at the time of the reported event was not returned for analysis.Multiple attempts to obtain the product and additional information were unsuccessful.As a result, the reported event could not be confirmed and the root cause could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.The centrimag primary console operating manual (doc.#(b)(4)) section 10-"emergency/trouble shooting" states: "the recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the back-up motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 1ST GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8290554
• MDR Text Key: 134530795
• Report Number: 2916596-2019-00227
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 04/22/2019; 02/10/2020
• Supplement Dates FDA Received: 04/23/2019; 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1