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	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a charging issue was confirmed via analysis of the returned 14v battery.During testing, the returned 14v battery (serial number: (b)(6) was inserted into a known working test universal battery charger (ubc) and was not accepted for charge.Upon inserting the battery in the charging slot, a red light illuminated and the error code b0013 displayed on the ubc.The expected relative state of charge (rsoc) voltage for a fully charged battery pack is approximately 4.1 v; however, the rsoc voltage of the battery was measured to be approximately 3.0 v, indicating an issue with the internal components.Despite the observed issues, the battery¿s discharge time was tested using an electronic load based battery test system and the battery exceeded the design specification for discharge time.The battery was then fully charged within the system without any issues.Circuit analysis of the battery¿s internal printed circuit board (pcb) revealed that one of the components had become compromised.Due to the compromised component, the rsoc voltage was not being updated to the correct measurement, which would result in the reported event.The reported event was determined to be due to a compromised component on the main pcb; however, root cause of the damage to the component could not be conclusively determined through this analysis.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Heartmate 3 ifu (rev.D) section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook (rev.A) section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (visual and auditory), including battery faults displayed on the universal battery charger (ubc) and the actions to take if the issue does not resolve.The patient handbook and the instructions for use caution the user 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 patient handbook and the ifu caution the user 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 14v battery was inspected and accepted into the storage location on (b)(6) 2024.The 14v battery was shipped to the customer on (b)(6) 2024.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the battery had an error message "b0013".The battery was unable to be fully charged as the universal battery charger (ubc) pocket light would turn red when the battery was charging midway.The issue persisted when the affected battery was tested twice at the transplant office.The battery was exchanged.

• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24307457
• Report Number: 2916596-2026-00734
• Device Sequence Number: 9679757
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: (01)00813024010692(10)SY019-B052(11)240119
• 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): 02/10/2026

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: Lay User/Patient
• Device Model Number: 2465
• Device Catalogue Number: 2465
• Device Lot Number: SY019-B052
• 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: 01/30/2026
• Initial Report FDA Received Date: 02/10/2026
• 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 Sex: Male
• Patient Weight: 65 KG