MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE® SEALED LEAD ACID BATTERY; VENTRICULAR (ASSIST) BYPASS

Model Number	109200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power module battery malfunctioned.
Additional Manufacturer Narrative
There was no patient involved in this event.The pma# provided is associated with most recent approval.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a red battery symbol on the power module was not confirmed.It was reported that the issue was resolved by exchanging the power module backup battery.It was reported that the exchanged battery would not be returned for evaluation.The root cause of the reported event could not be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.Heartmate 3 instructions for use (ifu) under section 7 ¿alarms and troubleshooting¿ and the power module instructions for use under section 5.0 ¿power module (pm) alarm conditions¿ cover all power module alarms and the actions to take when an alarm occurs.Power module precautions are documented in the heartmate power module instructions for use (ifu) under section ¿precautions¿.Section 4.0 ¿power module (pm) backup power¿ describes the usage of the backup battery and the power module visual indicators used to determine the status of the backup battery.The power module instructions for use (ifu) instructs the user on how to routinely inspect, clean, and maintain the power module.Section 2, entitled ¿setting up the power module (pm) prior to use¿ informs the patient not to use a power module that appears damaged, and to obtain a replacement if needed.Heartmate 3 instructions for use (ifu) section 8 ¿equipment storage and care¿ describes how to care for and clean all equipment, including the power module.Section f, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of the heartmate 3 lvad equipment, including the power module.Heartmate 3 patient handbook 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.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
Additional information was provided that when the battery was connected, a red battery symbol lit up.Troubleshooting was performed by charging the battery which did not work.Therefore, the battery was exchanged which successfully repaired the issue.

• Brand Name: HEARTMATE® SEALED LEAD ACID 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: 21106208
• Report Number: 2916596-2024-52855
• Device Sequence Number: 8774774
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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: 11/30/2025
• Device Model Number: 109200
• Device Catalogue Number: 109200
• Device Lot Number: GW354
• Was Device Available for Evaluation?: No
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2022
• 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