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	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power module alarmed with red battery.The battery was to be replaced via preventive maintenance.
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 the power module backup battery (serial number: (b)(6)) causing a red battery alarm was confirmed.Tech services replaced the backup battery on 22jul2024 and confirmed that the power module functioned as intended after replacement.The backup battery was manufactured on 04jun2021 and expired on 31may2024.The backup battery was scrapped.The root cause for the reported event was determined to be the power module backup battery expiring.Inspection data for the sealed lead acid battery (serial number: (b)(6)) was reviewed and showed the battery passed inspection.The battery expired on 31may2024.Heartmate 3 instructions for use under section 7 ¿alarms and troubleshooting¿ and heartmate 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.Heartmate 3 instructions for use section 3 "powering the system" and heartmate power module instructions for use under "introduction" explain how to set up the power module for use, including how to install the power module backup battery, and how to use the power module.Heartmate 3 instructions for use section 8 "equipment storage and care" and section f "safety checklists, and heartmate power module instructions for use under "inspection cleaning and maintenance" explain how to care for and clean the power module and provides checklists for performing routine maintenance of the power module.The heartmate 3 patient handbook and the heartmate 3 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.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
The battery was replaced via preventive maintenance resolving the alarm.

• 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: 19862275
• Report Number: 2916596-2024-05070
• Device Sequence Number: 12643190
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566(10)GV155206(17)240531
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: 05/31/2024
• Device Model Number: 109200
• Device Catalogue Number: 109200
• Device Lot Number: GV155206
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2021
• 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