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

Model Number	109200
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section g4: 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 complete.
Event or Problem Description
It was reported that the ventricular assist device (vad) coordinator was notified by the biomed that when exchanging the power module backup batteries during preventative maintenance, two power module backup batteries failed out of the box.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a power module backup battery not operating as intended was confirmed via evaluation of the returned heartmate 12 volt (v) power module backup battery (serial number (b)(6)).The returned 12v battery was connected to a test power module fixture and mock circulatory loop.The yellow charge symbol was illuminated followed shortly by the red battery and yellow wrench symbols.The alternating current (ac) power cord was unplugged, and the backup battery was unable to supply power to the system.Further evaluation was not performed due to the chemical hazard posed by sealed lead acid batteries.Provided information stated that there was no impact to the power module due to the backup battery issue.Additionally, no patient was being supported during the event.The root cause for the reported event was unable to be conclusively determined through this analysis.A manufacturing analysis task has been initiated to further investigate the issue of power module backup battery yellow wrench and red battery alarms.The testing records were reviewed for the 12v power module backup battery (s/n: (b)(6)) and it was found that the battery operated as intended.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Heartmate 3 ifu section 7 - ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 - ¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot atypical alarms, including all power module alarm conditions.Heartmate 3 ifu, section 8 - ¿equipment storage and care¿, and heartmate 3 patient handbook, section 6 - ¿caring for the equipment¿, explain how to properly care for all the equipment to prevent damage.Once every three years the power module internal battery will be replaced with a new internal battery.Heartmate 3 ifu, section 3 - ¿powering the system¿, states that the power module contains an internal backup battery that provides approximately 30 minutes of backup power to the system during a power emergency.It instructs to keep the power module plugged into ac power at all times to make sure that the power module backup battery is charged and ready for use in case of power interruption.If the power module is without ac power for approximately 18 hours or more, the power module backup battery may be damaged.Additionally, it is stated that if the power module backup battery is not installed or connected when the power module is plugged in, the power module alarms, indicating that it cannot provide backup power in the event of a power interruption.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® 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: 22075492
• Report Number: 2916596-2025-03039
• Device Sequence Number: 21207515
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566(17)270731
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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 Model Number: 109200
• Device Catalogue Number: 109200
• Device Lot Number: 10487002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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: Unknown