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

Model Number	2465
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a red light when charging the heartmate 14v li-ion battery out-of-box was confirmed during evaluation of the returned 14v battery.The returned battery, serial number (b)(6), was connected to a known working test universal battery charger (ubc) and a red light illuminated and a b0013 (relative state of charge (rsoc) line test) error code displayed on the ubc.The rsoc voltage was observed to be below the expected value.A manufacturing analysis task was initiated to investigate a b0013 error on a 14v battery out-of-box.The root cause was traced to a damaged capacitor on the main printed circuit board assembly (pcba) of the battery.The capacitor manufacturing processes were updated by the supplier to prevent further occurrences.The device history record was reviewed for the heartmate 14v li-ion battery, serial number (b)(6).The battery was inspected and accepted into storage on 20sep2024.The current revision of the instructions for use (ifu) and patient handbook can be found on the eifu page of the abbott website.The heartmate 3 lvas ifu heartmate 3 patient handbook are currently available.Section 3 of the ifu, entitled ¿powering the system¿, provides instruction on how to properly calibrate the 14v batteries, how to charge the battery, and how to check the charge level of the battery.Section 8 of the ifu, entitled ¿equipment storage and care¿, provides instruction on how to properly care for the 14v batteries.The patient handbook 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.
Event or Problem Description
It was reported that the 14v lith-ion battery had a red light in the battery charger straight out of the box.

• 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: 23948668
• Report Number: 2916596-2025-08201
• Device Sequence Number: 10683793
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: (01)00813024010692(10)GY242-B061(11)240829
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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): 01/02/2026

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: Health Professional
• Device Model Number: 2465
• Device Catalogue Number: 2465
• Device Lot Number: GY242-B061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2025
• 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: 12/19/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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 Sex: Unknown