MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY; VENTRICULAR (ASSIST) BYPASS

Model Number	106128
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d1: corrected.Section d4 (catalog number): corrected.Section d4 (udi): corrected.Manufacturer's investigation conclusion: the reported event of the out-of-box 11v backup battery (serial number: (b)(6)) not working properly and producing a backup battery fault alarm was not able to be confirmed.The battery was returned for analysis in unremarkable physical condition with 12.16v of charge.The battery was functionally tested alongside multiple test system controllers and was found to perform as intended each time.The backup battery was able to support operation of a mock circulatory loop without issue.The reported event of backup battery fault alarms was not able to be reproduced, and the root cause of the reported event could not be conclusively determined through this analysis.The initial inspection testing was reviewed for the backup battery (serial number: (b)(6)) and it was found that the battery passed.The backup battery was inspected and accepted into the storage location on 03jan2024.The heartmate 3 instructions for use (ifu) (section 2 ¿system operations¿) states that it may be necessary to install a replacement backup battery if the current one expires, or if prompted by a backup battery fault alarm.This section describes how to properly remove or install a backup battery within the controller.The heartmate 3 patient handbook (section 5 ¿alarms and troubleshooting¿) covers all alarms (visual and audible), including those associated with backup battery fault conditions, and the actions to take if the alarm cannot be resolved.The patient handbook cautions 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
It was reported that the patient had three battery faults over the last 5 months.Log files captured backup battery fault alarms on (b)(6) 2024 due to the ebb failing the load test.The patient had a low international normalized ratio (inr) due to a gastrointestinal (gi) bleed.They were unwilling to risk a stroke from a system controller exchange, so they opted for an emergency backup battery (ebb) exchange.The new ebb did not work the first time using it and produced a backup battery fault alarm.A different ebb was used.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

• Brand Name: THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP 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: 19124086
• Report Number: 2916596-2024-02057
• Device Sequence Number: 7629144
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: (01)00813024011255(17)251114
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/27/2024

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: Lay User/Patient
• Device Model Number: 106128
• Device Catalogue Number: 106128
• Device Lot Number: 10139798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/29/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 107 KG