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

Model Number	106531US
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced numerous power cable disconnect alarms hours apart.It was said that the alarms occurred when the patient was walking, sitting, and lying down.The alarms were said to also have occurred before and after the patient fell while lying on a gurney.Upon initial interrogations the alarms did not appear to show on the system controller nor monitor.Log files were submitted for review and captured unusual power cable disconnect alarms while the patient was on battery power.The alarms appeared to be the result of relative state of charge (rsoc) invalid flags.All connections were checked and different batteries and two set of clips were tried but the alarms persisted.The alarms resolved when the system controller was exchanged.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

• 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: 50951041
• Report Number: 2916596-2026-2920235
• Device Sequence Number: 9552216
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Expiration Date: 04/23/2026
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: L00000709
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 180 LB
• Patient Race: White