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	12/11/2024
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.Manufacturer's investigation conclusion: the reported event of the power module (serial number: (b)(6)) producing a red battery alarm was not able to be confirmed through this evaluation.Provided information indicated that the heartmate sealed lead acid battery (serial number: (b)(6)) was replaced in response to the observed alarm.The power module was reportedly being used for a training session, and there was no patient involved.No products returned to abbott for evaluation.The root cause of the reported event cannot be conclusively determined through this analysis.Battery inspection data was reviewed for the 12v sla backup battery, serial number (b)(6), revealing that the battery passed all inspection testing.The heartmate iii instructions for use (rev.G, section 7) instructs users on how to handle red battery alarms that occur on the power module.A red battery alarm with a yellow wrench alarm signifies that the internal backup battery is not functioning properly.Users are instructed to immediately switch to a new power source.The heartmate power module ifu (rev.C), section 2.0 ¿setting up the power module (pm) prior to use¿ describes how to prepare the power module for use by connecting the internal battery, attaching the power cord, and attaching the patient cable.The heartmate iii instructions for use (rev.G) 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 (rev.G) 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 the power module was correctly connected to ac power and showed green symbols.The power module alarmed and the battery symbols turned red.The battery status and connections were checked and no abnormalities were detected.The battery was depleted and needed to be replaced.

• 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: 21067604
• Report Number: 2916596-2024-52666
• Device Sequence Number: 8372980
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566(17)251130
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2025

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: 12/11/2024
• Initial Report FDA Received Date: 01/03/2025
• 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