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

Model Number 201-30300

Device Problem Battery Problem (2885)

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

Event Date 06/11/2019

Event Type  malfunction  

Event Description

Upon switching patient over to new centrimag console, the machine alarmed b4 battery maintenance.Patient had to be switched over to a backup centrimag console.This was a new device, unclear why it failed upon being placed on a patient.Manufacturer response for centrimag ventricular assist device., (brand not provided) (per site reporter).They are looking into it.

• Brand Name: CENTRIMAG
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 8955918
• MDR Text Key: 156299440
• Report Number: 8955918
• 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: 06/12/2019

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 Model Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7300 DA