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

Model Number	2465
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that battery was unable to fully charge.The affected battery as the universal battery charger (ubc) pocket light would turn red when the battery was charging mid-way.Issue persisted when the affected battery was tested twice at the transplant office.The alarm was b0003.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the 14v li-ion battery (serial number: (b)(6) producing a b0003 error when inserted into the universal battery charger (ubc) was confirmed.The 14v battery returned in unremarkable physical condition.The 14v battery passed all functional testing without issue.However, after testing, when the battery was re-inserted into a test ubc, the fault was reproduced, confirming the reported event.The b0003 error indicates a cell imbalance issue.The battery was opened, and the cells were individually measured and found to be balanced.The issue was traced to a problem with the printed circuit board (pcb).The root cause of the b0003 error was determined to be due to damage to the battery¿s main printed circuit board.The root cause of the damage was not able to be determined via this investigation.The initial testing records were reviewed for the 14v li-ion battery (serial number: (b)(6) and it was found that the battery operated as intended.It was noted that the initial wake up procedure was performed on (b)(6) 2024, and it was next due to be charged on 14jan2025.The battery was shipped from (b)(4) distribution center on 15feb2024.The battery was then shipped from the (b)(4) distribution center to the customer on 21feb2024.Heartmate 3 instructions for use and heartmate 3 patient handbook cover all alarms, including faults that occur on the ubc, and the actions to take if the faults do not resolve.The heartmate 3 patient handbook and heartmate 3 instructions for use 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.No further information was provided.The manufacturer is closing the file on this event.

• 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: 23367171
• Report Number: 2916596-2025-06819
• Device Sequence Number: 12979307
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: (01)00813024010692(10)SY019-B055(17)270119
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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 Model Number: 2465
• Device Catalogue Number: 2465
• Device Lot Number: SY019-B055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2025
• 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: 09/29/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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: 24 YR
• Patient Sex: Male
• Patient Weight: 101 KG