MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER; Ventricular (assist) bypass

Model Number	106531US
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a system controller exchange was performed by the nurse after stating there was a fault alarm displayed on the system controller screen before the system controller went blank.Log file review revealed no unusual event prior to the system controller exchange.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of an unknown fault alarm and a blank display on the system controller was not confirmed.A review of the submitted primary controller event log file (b)(4) spanned approximately 14 days (on (b)(6) 2026 per time stamp).The driveline was disconnected on (b)(6) 2026 at 13:59:06.There were no notable alarms active in the log file.A review of the submitted controller periodic log file (b)(4) spanned approximately 12 days at 1-hour intervals (on (b)(6) 2026 per time stamp).There were no notable alarms active in the log file.The system controller, serial: (b)(6), was not returned for analysis.There were no photos of the display provided.The provided information stated that the system controller displayed a fault alarm before the screen went blank.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no response was received.A root cause for the reported event was not conclusively determined through this analysis.The patient handbook and ifu also 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.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Heartmate 3 instructions for use section 7-¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5-¿alarms and troubleshooting¿ explain how to troubleshoot all system controller alarms.Heartmate 3 instructions for use section 8-¿equipment storage and care¿ and heartmate 3 patient handbook section 6-¿caring for the equipment¿ explain how to properly take care and maintain the integrity of the system controller.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER
• Common Device Name: Ventricular (assist) bypass
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24368573
• Report Number: 2916596-2026-00772
• Device Sequence Number: 15872942
• Product Code: DSQ
• UDI-Device Identifier: 05415067039446
• UDI-Public: (01)05415067039446(17)270620
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: L00003967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American