MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; VENTRICULAR (ASSISST) BYPASS

Model Number 106531US

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2021

Event Type  malfunction  

Event Description

It was reported that the system controller alarm review only showed a blank screen.Alarm were reportedly unseen on clinical screen.It was reported that system check was normal and still blank screen for alarm review.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the reported event of the controller showing blank screen when reviewing alarms was not confirmed.A review of the submitted log file spanned approximately 11 days (b)(6) per time stamp).There were no notable alarms active in the log file.The heartmate3 system controller (serial (b)(6) was not returned for analysis.Multiple attempts were made to obtain additional information, without response.A root cause for the reported event cannot be conclusively determined through this analysis.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.Heartmate 3 instructions for use section 4, ¿system monitor-history screen¿ explains how to review and retrieve the system events/alarms and data log files.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11319812
• MDR Text Key: 232441992
• Report Number: 2916596-2021-00303
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2023
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7536165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 73