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

Model Number	106531US
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had an emergency backup battery (ebb) fault alarm (b)(6) 2026.The system controller was exchanged.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a backup battery fault alarm was not confirmed.The system controller (serial number unknown) was not returned for analysis, and no log files were provided.Available information for this event indicates that the controller was exchanged to resolve the issue.Questions regarding the event were asked multiple times and no responses were received.The root cause of the reported event was unable to be conclusively determined through this analysis.A corrective action was initiated in order to further investigate backup battery fault alarms.The heartmate 3 patient handbook section 5 ¿alarms and troubleshooting¿ and the heartmate 3 lvas instructions for use section 7 ¿alarms and troubleshooting¿ instructs users on how to identify and respond to alarms that sound from their controller, including backup battery fault alarms.The heartmate 3 patient handbook section titled "emergency contact list" cautions 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 revisions of the patient handbook and instructions for use (ifu) can be found on the eifu page of the abbott website.The serial number of the system controller was not provided.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 ; +1(781)852-8207
• MDR Report Key: 50946623
• Report Number: 2916596-2026-2919838
• Device Sequence Number: 16063960
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse Practitioner
• Remedial Action: Notification
• 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
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q325-HF-4
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male