MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BACK-UP CONSOLE WITH BATTERIES; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2017

Event Type  malfunction  

Event Description

Multiple consoles have shown motor disconnected when the centrimag pump is connected to the console.Pt was at home on the heart device (ventricular assist device).

• Brand Name: CENTRIMAG BACK-UP CONSOLE WITH BATTERIES
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 9255239
• MDR Text Key: 164276307
• Report Number: 9255239
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2019
• Event Location: Other
• Date Report to Manufacturer: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1