MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, 14V LI-ION RECHARGEABLE BATTERY SET; VENTRICULAR (ASSIST) BYPASS

Model Number	2465
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that a report was made of faulty equipment, with the universal battery charger (ubc) and batteries smoldering.The ubc lights all turned red.Equipment was disconnected from mains and isolated.Fire department was called to isolate equipment.The account did their own internal investigation and concluded that saline was spilt into the ubc, which was believed to be the cause of the incident as opposed to a faulty ubc.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of fluid ingress and red light on the heartmate universal battery charger (ubc) was not confirmed during evaluation of the returned heartmate 14v li-ion battery.The returned battery, serial number (b)(6), was visually inspected and found to be physically unremarkable.The battery was functionally tested and found to operate as intended during testing.The battery was inserted into a test universal battery charger (ubc) and accepted for charge.The battery was fully charged and discharged using an electronic load based battery test system and the battery exceeded the requirement for discharge time.The battery was tested with a test system controller, 14v battery clip, and mock circulatory loop and the battery powered the system without issue.Although not confirmed, per provided information, the root cause of the reported event was determined to be due to user error in spilling saline onto the ubc and batteries.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 30apr2024.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 and heartmate 3 patient handbook are currently available.Section 3 of the ifu, entitled ¿powering the system¿, instructs the user to keep the 14v li-ion batteries clean and dry.This section also 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.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.

• 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: 22815478
• Report Number: 2916596-2025-05478
• Device Sequence Number: 13015306
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: (01)00813024010692(10)GY100-B031(11)240409
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: GY100-B031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 78 KG