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

Lot Number L05851-006

Device Problem Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 12/18/2018

Event Type  malfunction  

Event Description

The perfusionist came into the room and felt the motor and found it to be extremely hot to the touch.This could result in a fire or abrupt shut down of the device.Since this device helps to control the patient's heart rate, it could be catastrophic if it does fail.Both the motor and console were exchanged.The entire circuit was also exchanged.

• Brand Name: CENTRIMAG
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; 6035 stoneridge dr; pleasanton CA 94588
• MDR Report Key: 8260243
• MDR Text Key: 133524601
• Report Number: 8260243
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/20/2018

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: No Information
• Device Lot Number: L05851-006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13505 DA