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

Model Number	106128
Medical Device Problem Codes	Mechanical Problem (1384); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d5: operator of device corrected section g4: there was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.Section h6: health effect - impact code and medical device problem code corrected manufacturer¿s investigation conclusion: the reported event of a bent pin within the system controller¿s backup battery was unable to be confirmed.The 11v backup battery (serial number: (b)(6) was not returned for analysis and no log files nor images were submitted for review.Multiple good faith efforts were sent asking if any product would be returned for analysis.To date, no response has been received.A root cause for the reported event was unable to be conclusively determined through this investigation.The heartmate 11v backup battery (serial number: (b)(6) was inspected and accepted into the receiving inspection storage location on (b)(6) 2024 and passed all manufacturing testing.Heartmate 3 instructions for use (rev.C) section 8 entitled ¿equipment storage and care¿ and heartmate 3 patient handbook (rev.D) section 6 "caring for the equipment" describes how to care for and clean all equipment including the system controller power cables and power cable connectors.Heartmate 3 patient handbook (rev.D) and heartmate 3 instructions for use (ifu) (rev.C) caution 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.
Additional Manufacturer Narrative
Manufacturer¿s investigation conclusion: the reported event of a bent pin within the system controller¿s backup battery was confirmed.The heartmate 11 volt lithium-ion backup battery (serial number: (b)(6)) was returned with a bent pin #1.An attempt was made to connect the battery to a test controller; however, the bent pin prohibited the connection.The pin was bent back to its original state to continue testing.After connecting the battery to a test system controller, the controller was connected to a mock circulatory loop and the controller and backup battery functioned as intended throughout testing.A root cause for the bent pin was unable to be conclusively determined through this analysis.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.No further information was provided.The manufacturer is closing the file on this event.
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 backup battery (ebb) was taken out of box and would not engage with the system controller.After inspection, they found that it was due to a bent pin in the ebb.

• 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: 21191721
• Report Number: 2916596-2025-00110
• Device Sequence Number: 3441889
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: (01)00813024011255(17)260724(11)240824
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 03/11/2025

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: 07/24/2026
• Device Model Number: 106128
• Device Catalogue Number: 106128
• Device Lot Number: 10505240
• 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: 12/31/2024
• Supplement Date Received by Manufacturer: 01/22/2025; 02/17/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 01/23/2025; 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2024
• 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