MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE® SEALED LEAD ACID BATTERY; Ventricular (assist) bypass

Model Number	1340
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s investigation conclusion: the reported event of an alarm on the power module was not confirmed via the returned heartmate 12v power module backup battery.The returned 12v backup battery, serial number: (b)(6), was connected to a known working test power module for an extended period and no alarms or issues were reproduced.The backup battery was able to support a mock circulatory loop.The provided information indicated the power module was no longer associated with a patient and is used strictly for educational purposes.The backup battery was reseated however the alarms did not resolve.A root cause for the reported event was not conclusively determined through this analysis.The device history record was reviewed for the 12v power module backup battery, serial number: (b)(6).The battery was inspected and accepted into storage on 16dec2024.The heartmate 3 instruction for use was available for use at the time of the event.Section 7, entitled ¿alarms and troubleshooting¿, provides instructions on how to identify and resolve power module alarms.The heartmate 3 instructions for use, section 3, entitled ¿powering the system¿, also instructs the user to prevent the power module from being disconnected from ac power longer than 18 hours to prevent damaging the unit¿s backup battery.The heartmate 3 patient handbook which was available for use at the time of the event, 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.
Event or Problem Description
It was reported that maintenance was performed on an education power module, but the next day it was alarming.Troubleshooting was performed and the battery was reseated but it did not resolve the issue.The power module was replaced.It was later reported that the power module was no longer attached to a patient at the time of the event and was strictly being used for educational purposes.It was noted that the 12v battery placed in the power module was faulty and it was returned.

• 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: 21434719
• Report Number: 2916596-2025-00950
• Device Sequence Number: 4606198
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566(17)271130
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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): 02/21/2025

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: 1340
• Device Catalogue Number: 1340
• Device Lot Number: GY340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• 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: 02/04/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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