MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, 11 VOLT LI-ION BACKUP BATTERY; Ventricular (assist) bypass

Model Number	106128
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the backup battery (serial number: (b)(6)) was returned for evaluation.The returned backup battery was functionally tested and found to operate as intended during testing.The backup battery was installed in a test system controller and operated in a mock circulatory loop without any issues or atypical alarms produced.The controller was disconnected from external power and the battery supported the pump without any issues.An attempt was made to determine why the backup battery was returned for evaluation; however, the information was not provided.The reported event could not be correlated to an issue with the returned backup battery.A foreign contaminate was observed within the backup battery connector battery inspection data was reviewed for the 11v backup battery, serial number (b)(6), revealing that the battery passed all inspection testing.The backup battery was shipped to the customer on 25jul2022 heartmate 3 instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (visual and auditory), including backup battery fault alarms and the actions to take if the alarm cannot be resolved.Heartmate 3 instructions for use section 5 ¿ ¿surgical procedures¿, explains how to install the backup battery in the system controller.Additionally, section 2 ¿ ¿system operations¿, explains how to properly replace the backup battery.The patient handbook and the 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 backup battery was received for evaluation.No information could be provided.

• 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: 20429233
• Report Number: 2916596-2024-06828
• Device Sequence Number: 12669190
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: (01)00813024011255(10)8494697(17)240412
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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 Expiration Date: 04/12/2024
• Device Model Number: 106128
• Device Catalogue Number: 106128
• Device Lot Number: 8494697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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 Sex: Unknown