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	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 yellow wrench lamp and the red battery alarm lamp illuminated when the built-in power module (pm) battery purchased for periodic replacement was replaced and switched to battery drive.The built-in battery was not used because the reproducibility was confirmed.
Additional Manufacturer Narrative
H8 - usage of device: correction.Manufacturer's investigation conclusion: the reported event of yellow wrench and red battery indicator issue could not be confirmed with the returned 12v sealed lead acid battery (serial # (b)(6)).The 12v battery was installed into a test power module and an expected yellow battery charging indicator was active.The battery completed the charge process when the battery charging indicator turned green.The system was able to operate on the battery until a red battery alarm became active approximately 67 minutes later.The battery pass specification, which is greater than 60 minutes.The battery functioned as intended and the reported yellow wrench and red battery indicator issue could not be reproduced.A root cause of the reported yellow wrench and red battery indicator issue could not be determined through this evaluation.The complaint does not meet the requirement of the investigation procedure for a review of the device history records.Heartmate 3 instructions for use has details on the proper use of the power module.If the power module does not function properly, contact the company's technical service department for assistance.Under section 3, ¿powering the system¿, describes all audible and visual alarms.Also, under this section, indicator symbols on the front panel of the power module illuminate to indicate the charge status of the power module backup battery.Table 3.1 describes the indicator symbols.To set up the power module, perform these tasks: install the power module backup battery.Connect the power cord.Connect the power module patient cable.In section f, safety checklists, replace any equipment or system component that appears damaged or worn.¿yearly safety checklist¿, schedule a power module inspection and cleaning with thoratec-trained personnel.The inspection and cleaning includes (but is not limited to) functional testing, cleaning, inspection, and replacement of the power module backup battery.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: 20926469
• Report Number: 2916596-2024-52428
• Device Sequence Number: 5294180
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566(17)260430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: Lay User/Patient
• Device Expiration Date: 04/30/2026
• Device Model Number: 109200
• Device Catalogue Number: 109200
• Device Lot Number: GX125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 63 KG