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

Model Number	106762
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the log files were submitted for evaluation concerning backup battery faults.The patient replaced the emergency backup battery (ebb) at visit on (b)(6) 2025 due to the ebb expiring.When the patient tried to charge the system controller at home, an ebb fault alarm occurred.This also occurred as well at the clinic once plugged into monitor.The controller was plugged into the monitor to get the attached wave forms and the system controller and battery were resynced.Ebb faults were still present following this.The backup controller was exchanged, and the exchanged controller was intended to return for evaluation.The battery was plugged in and there was an attempt to get the pins inserted but they would not fully click after trying to get new battery from 14nov2025 seated correctly.Log files indicated that the faults associated with the ebb was a backup battery uninstalled and a backup battery signal fault.These events had been intermittently active since (b)(6) 2025.These events indicated that the ebb was not properly connected to the system controller or there was an issue with the ebb.
Additional Manufacturer Narrative
No further info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
No further information was provided.The manufacturer is closing the file on this event.The reported event of a backup battery fault alarm occurring on the patient¿s backup controller was confirmed via the log file and via the controller¿s functional analysis.The log file captured a few intermittent backup battery fault alarms from 14nov2025 ¿ 18nov2025; the controller was not connected to the pump throughout this data.The alarms correlated to the black cable being disconnected from power, and no other notable events were observed.The returned system controller (serial number (b)(6)) was functionally tested and entered run mode upon being connected to power, followed by alarming with a backup battery fault alarm after the driveline was connected and when the black cable was disconnected from power.The controller¿s backup battery ribbon cable was inspected and was found to have a detached wire.The detached wire correlates to the battery¿s connection to the black cable, consistent with the reproduced alarms and log file findings.This wire being detached could have also contributed to the reported atypical connection of the battery.The wire was reattached to the connector which resolved all issues.Then, the controller was functionally tested and fully performed as intended.The root cause of the reported event was determined to have been due to the backup battery ribbon cable becoming damaged; however, the root cause of this damage was unable to be conclusively determined.Review of the device history record for the system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) with heartmate touch (rev.A), section 7 - ¿alarms and troubleshooting,¿ explains how to properly interpret and troubleshoot backup battery fault alarms.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.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23760475
• Report Number: 2916596-2025-07634
• Device Sequence Number: 9992663
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: (01)00813024011286(17)240418
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/12/2026

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: 04/18/2024
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 7971747
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 140 KG