MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number	106762
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient seen today in clinic for routine visit.It was noticed that the green circle on their system controller was very dim and not easily visible.The last documented system controller exchange was (b)(6) 2023.It was decided to change their system controller on (b)(6) 2025 while the patient was in clinic.There was no reported damage to the system controller by the patient.Log files contained a few clusters of pulsatility index (pi) events as well as routine power source changes.There were no abnormal alarms or events recorded.The pump appeared to be operating as intended.It was agreed that the system controller should be replaced.
Additional Manufacturer Narrative
No further info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the system controller¿s green pump indicator light emitting diodes (leds) being dim was confirmed.The returned system controller (serial number (b)(6)) was functionally tested, and its green pump indicator leds were observed to be dim; however, the controller functioned and operated a mock loop as intended throughout all testing.The provided log file did not capture any atypical events, and the pump operated as intended throughout the data.Available information for this event indicates that the controller was exchanged to resolve the issue.The root cause of the reported event was unable to be conclusively determined through this analysis, and a corrective action was initiated to address the hmii system controller¿s green pump indicator leds becoming dim.This controller was manufactured prior to the corrective action¿s implementation.Review of the device history record for system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The heartmate ii patient handbook (rev.C, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment for damage, including damage to the system controller, and to obtain replacements if needed.The heartmate ii patient handbook (rev.C, 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.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
No further info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Event or Problem Description
The system controller was replaced and the issue was resolved.The site kept the controller so it could be returned for evaluation.

• Brand Name: THORATEC® HEARTMATE II®, 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: 23780511
• Report Number: 2916596-2025-07809
• Device Sequence Number: 10105617
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: (01)00813024011286(17)190831
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2026

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: 08/31/2019
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 01/21/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/18/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2016
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 102 KG