MAUDE Adverse Event Report: Thoratec Corporation Thoratec® HeartMate 3¿ System Controller; Ventricular (Assist) Bypass

Model Number	106531US
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced a driveline communication fault on (b)(6)2026.The patient panicked and switched to their backup system controller.The patient stated that after a few minutes, the backup controller had the same error, so they switched back to their primary controller.Review of log files from the primary controller found single communication faults (comm a) starting at 15:53 on (b)(6)2026 that continued until the controller was exchanged at 15:55.Review of the backup controller log file showed the driveline was connected at 15:55 on (b)(6)2026 and comm a faults reoccurred at 17:39, with the patient switching back to the original controller at 17:46.No further comm faults were noted in the log files after the patient switched back to the original primary controller.The customer stated that there were no visible cracks, slits, or damage to pump or modular cables.However, some debris was noted around the yellow line at the modular cable-pump cable connector.That debris was cleaned.The patient was then provided a new system controller and modular cable.There were no further alarms reported following the exchange to the new controller and new modular cable, and the customer confirmed the alarms had resolved.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

• 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 ; +1(781)852-8207
• MDR Report Key: 50947171
• Report Number: 2916596-2026-2920189
• Device Sequence Number: 13149566
• Product Code: DSQ
• UDI-Device Identifier: 05415067039446
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/30/2026

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: L00007246
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2026
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 151 LB