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

Model Number	106762
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Event or Problem Description
It was reported that the patient had multiple power cable disconnects originating from the black controller power cable.Patient also reportedly had dizziness, high flow and high power on (b)(6) 2025.They were otherwise asymptomatic.Log files were submitted for review.Log file review by tech services confirmed numerous power cable disconnects on (b)(6) 2025 on the white power cable while connected to battery power, and numerous power cable disconnects on (b)(6) 2025 on the black power cable while on battery power.No alarms occurred while connected to the power module.Log file review did not appear to capture any notable alarm conditions or parameter changes, and that the mcs equipment was operating as intended electronically and mechanically.It was later reported that the reported issue was caused by problems with the controller or battery clips.The patient had both primary and backup controller exchanged and was given a new set of batteries and battery clips.There was no documented reason for the backup controller to also be exchanged, but the controller, battery, and battery clip exchanges resolved all alarms.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of atypical power cable disconnect alarms on the system controller (serial number: (b)(6) were confirmed via log file analysis.Data from the reported event date of 24oct2025 ¿ 27oct2025 was reviewed.Several times in the data reviewed, intermittent, atypical power cable disconnect alarms were noted due to the relative state of charge (rsoc) signal fluctuating around the alarm threshold on both power cables.The power cable disconnect alarm did not prevent the controller from operating the pump at its set speed.Provided information indicated that the alarms resolved when the controller, 14v li-ion batteries, and battery clips were exchanged.The root cause of the reported events was not able to be determined via this investigation.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.Heartmate ii instructions for use section 7-¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot low voltage alarms.The device history records was reviewed and revealed no deviations from manufacturing or qa requirements.No further information was provided.The manufacturer is closing the file on this event.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23689424
• Report Number: 2916596-2025-07394
• Device Sequence Number: 9124320
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: (01)00813024011286(17)240913
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 12/18/2025

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: 09/13/2024
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 8759784
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2022
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 86 KG