MAUDE Adverse Event Report: Thoratec Corporation THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY; Ventricular (Assist) Bypass

Model Number	106128
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was sticky substance under the system controller battery.Log files were sent for review.There were no unusual events recorded in the log files.The device operated as expected.There were no known alarms.The patient was due of 11v battery replacement, and the issue was noticed upon opening the back cover.The system controller and battery were replaced.The event resolved.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of fluid ingress on the backup battery (serial number: (b)(6)) was confirmed via customer submitted photo.The customer submitted photo showed evidence of fluid ingress in the backup battery compartment and on the backup battery.The submitted log files showed no indication that the fluid ingress prevented the system controller from supporting the system in the data reviewed.The root cause of the fluid ingress was not able to be conclusively determined via this investigation.Battery inspection data was reviewed for the 11v backup battery, serial number (b)(6), revealing that the battery passed all inspection testing.The heartmate 3 left ventricular assist device (lvas) instructions for use (ifu), and the heartmate 3 patient handbook, are currently available.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Section 10 of the patient handbook, ¿safety checklists¿, instructs users to regularly inspect their equipment, including their system controllers, and to avoid using equipment that appears damaged.Users are encouraged to replace any equipment that appears damaged.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY
• 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: 50897927
• Report Number: 2916596-2026-2920029
• Device Sequence Number: 16130425
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: (01)00813024011255(17)251007(11)231107
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/25/2026

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: 10/07/2025
• Device Model Number: 106128
• Device Catalogue Number: 106128
• Device Lot Number: 10109999
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2023
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 246 LB
• Patient Race: White