MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY; Ventricular (assist) bypass

Model Number	106128
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the backup battery (ebb) was used in an existing system controller and immediately had an ebb fault alarm.The ebb was used in another system controller and the same alarm occurred.A self-test did not clear the alarm and the ebb was replaced.The ebb had not yet been issued to a patient.The ebb was initially being charged for use when the ebb fault occurred.
Additional Manufacturer Narrative
Section g4: there was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.Manufacturer's investigation conclusion: the reported event of a backup battery fault alarm was confirmed via evaluation.The 11v backup battery (serial number: (b)(6)) was returned for analysis in unremarkable condition, and log files were not sent for analysis.The 11v backup battery was functionally tested and the reported backup battery fault alarm was reproduced.The 11v backup battery connected to a lab reference system controller and a backup battery fault alarm due to a circuit fault was active.The backup battery printed circuit board (pcb) underwent circuit analysis, and it was observed that component d52 was shorted.Provided information revealed that the battery had not yet been issued to a patient and that in an effort to charge the battery for use, the fault happened immediately.The root cause for the reported event was determined to be due to d52 being shorted.A manufacturing analysis task was opened under to further investigate this issue.The receiving and inspection documents for the emergency backup battery (serial number: (b)(6)) were reviewed and found to have passed.Heartmate 3 instructions for use section 2 ¿system operations¿ and heartmate 3 patient handbook section 2 ¿how your heart pump works¿ address how to properly maintain the backup battery over time.Heartmate 3 instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿alarms and troubleshooting¿ addresses how to properly interpret all system alarms including backup battery fault alarms.Additionally, it outlines actions to take if the alarms cannot be resolved.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: THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY
• 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: 21172388
• Report Number: 2916596-2025-00420
• Device Sequence Number: 13114864
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: (01)00813024011255(17)260401(11)240501
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/16/2025

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: Health Professional
• Device Expiration Date: 04/01/2026
• Device Model Number: 106128
• Device Catalogue Number: 106128
• Device Lot Number: 10360990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• 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: 01/15/2025
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown