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

Device Problems Temperature Problem (3022); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 10/03/2018

Event Type  malfunction  

Event Description

Motor head on centrimag had been making a loud whirring noise throughout day.This afternoon when perfusion rounded and checked the pump again, the motor was extremely hot to the touch and still making the noise.Decision was made to switch motor head into a new motor.

• 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: 7984035
• MDR Text Key: 124309701
• Report Number: 7984035
• 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: 10/05/2018

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
• 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: 10/05/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19710 DA