MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET; Ventricular (assist) bypass

Model Number	2465
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of damage to the 14v li-ion battery contacts was confirmed during evaluation.The heartmate 14v li-ion rechargeable battery (serial number: (b)(6) was returned for analysis with two corroded contacts, which pertained to the voltage signals of the battery.The second contact in from the left was corroded all the way through the contact.The 14v li-ion battery was functionally tested and passed all testing.The battery pack parameters correspond to a normal functioning pack that has been in use.The 14v battery was accepted for charge in test universal battery charger (ubc) without any issues or faults observed.The battery was connected to test battery clip, system controller, and mock circulatory loop and functioned as intended with no alarms active.The 14v battery was opened and no abnormalities were observed.A root cause for the reported event could not be conclusively determined through this investigation.The receiving and inspection documents for the 14v li-ion rechargeable battery (serial number: (b)(6) were reviewed and found to have passed.Heartmate 3 instructions for use (rev.D) section 8 ¿ ¿equipment storage and care¿ and heartmate 3 patient handbook (rev.A) section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment.Additionally, heartmate 3 patient handbook section 10 entitled ¿safety checklists¿, instructs users to regularly inspect their accessories for damage, and to replace any equipment that appears damaged or worn.Heartmate 3 patient handbook (rev.A) 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.
Event or Problem Description
It was reported that two of the patient's battery terminals were damaged.The damage created a hole in the battery terminal of both patient's batteries.The patient did not report a notable event that caused the damage and the batteries were stored in the patient's backup bag.The cause of damage was unknown.There was no damage to the consolidated bag.

• Brand Name: HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET
• 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: 22629983
• Report Number: 2916596-2025-05032
• Device Sequence Number: 9166619
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: (01)00813024010692(10)GW164-B042(11)220613
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/28/2025

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: 06/13/2025
• Device Model Number: 2465
• Device Catalogue Number: 2465
• Device Lot Number: GW164-B042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• 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: 07/24/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 109 KG