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	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the 14-volt battery not charging was confirmed via the battery¿s functional analysis.The returned 14-volt battery (serial number (b)(6) displayed 0 out of 5 bars on the fuel gauge upon arrival, and the battery was not accepted for charge in a known working test universal battery charger (ubc), displaying a b0001 error code with a red light.The battery was opened and troubleshoot, and the battery¿s cell voltage circuitry was observed to have been shorted to its communication circuitry, causing two of the battery¿s cells to read as 0 volts and rendering the battery unable to communicate with a ubc.The root cause of the reported event was determined to have been the battery¿s main printed circuit board (pcb) becoming electrically damaged; however, the root cause of how the main pcb became damaged was unable to be conclusively determined through this analysis.Device history records (dhr) for the 14-volt battery reside with the original equipment manufacturer (oem).However, the 14-volt battery was observed to have passed all initial manufacturing testing per the great batch manufacturing data sheet.The heartmate 3 patient handbook instructs users on how to properly use, charge, and calibrate 14-volt batteries.If a red light status becomes active on the ubc while the battery is charging, users are advised to not use that battery.The patient handbook also instructs users on how to check the current relative charge of the 14-volt batteries.Two batteries are expected to power the system for approximately 17 hours, and this can vary depending on activity level.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.The current revision of the patient handbook 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 according to the ventricular assist device (vad) coordinator, the team replaced a 14v battery they provided to the patient in january.The battery no longer charged and showed a red light on the universal battery charger (ubc).Error code b0001 showed on the ubc.It was stated that there were no dirt or debris noted, and the copper section of the battery was cleaned with alcohol, the battery was placed in different pockets, multiple different ubc's were tried, and the battery was left on the ubc for an extended period of time.

• 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: 23536406
• Report Number: 2916596-2025-07400
• Device Sequence Number: 10202548
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: (01)00813024010692(10)GY151-B112(17)270530
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/12/2025

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: GY151-B112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2025
• 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: 11/05/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White