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	12/11/2024
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 patient called the clinic to report that they received an intermittent alarm on their system controller.Upon interrogation, the controller alarm was found to be a "backup battery fault".Due to them not being able to find transportation to the clinic, the patient then silenced their alarm and a health nurse went over to exchange the system controller.The home health nurse successfully exchanged the patient's primary controller to their backup controller.The patient did experience quite a bit of anxiety from this exchange.The exchanged controller was returned to the clinic for further evaluation and was received on (b)(6) 2024.The old battery was removed and exchanged for a brand-new battery.The date and clock were set in accordance with protocol.However, a backup battery fault alarm was still displaying on the original controller that was received by the clinic.The battery was removed and reseated for an additional time, however there was difficulty in getting the wiring plate to sit surface with the battery itself.The controller was powered down and then repowered back up with a return of the backup battery fault alarm.Therefore, it appeared to be evident that the patient needed a brand-new backup controller.The same 11v lithium-ion battery was inspected further, prior to receiving into the new controller and there was evidence of a bent pin.This battery was replaced, and seating of the new battery was successful.The date and time were set accordingly and there were no additional alarms on the new controller.The patient was left in stable condition otherwise.
Additional Manufacturer Narrative
Manufacturer¿s investigation conclusion: the reported event of a bent connector pin in the 11v backup battery was confirmed via visual analysis.The heartmate 11v lithium-ion backup battery (serial number: (b)(6) was returned with a bent connector pin 11, and a log file was downloaded from the returned heartmate 3 system controller (serial number: (b)(6).A review of the log file contained events spanning approximately 5 days (01jan2000, 09dec2024 - 11dec2025, 17dec2024 per timestamp).The driveline was disconnected on (b)(6) 2024 at 10:12:51 and the system controller was shut down shortly after at 10:15:04.The system controller was powered back on at a default timestamp of (b)(6) 2000, indicating the system controller experienced a complete loss of power, which is consistent with the provided information of a backup battery exchange.The system controller¿s internal clock was set to the correct date and time at 10:16:19 on (b)(6) 2024 backup battery fault alarms were active on (b)(6) 2024 from 10:17:29 - 10:20:00 due to a backup battery circuit fault and backup battery memory tag fault.These alarms are consistent with the provided information and observed damage to the backup battery pin.The system controller was shut down at 10:20:02 on (b)(6) 2024.There were no other notable alarms active in the log file.The observed damage to the pin would result in an alarm due to the system controller¿s inability to properly connect to the backup battery.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, 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.The heartmate 11v backup battery (serial number: (b)(6) was inspected and accepted into the receiving inspection storage location on 02jul2024 and passed all manufacturing testing.Heartmate 3 instructions for us, section 7 entitled ¿alarms and troubleshooting¿ and heartmate 3 patient handbook, section 5 ¿alarms and troubleshooting¿ addresses how to properly interpret all system alarms including backup battery fault alarm.Additionally, it outlines actions to take if the alarms cannot be resolved.Heartmate 3 instructions for use, section 8 entitled ¿equipment storage and care¿ and heartmate 3 patient handbook, section 6 ¿caring for equipment¿ addresses how to properly maintain all components, including the backup battery as with time the battery depletes.Heartmate 3 instructions for use (ifu), section 2 "system operations" explains how to replace the system controller backup battery.Section 5 ¿surgical procedures¿ also explains how to install the backup battery in the system controller.The patient handbook 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.

• 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: 21117788
• Report Number: 2916596-2025-00202
• Device Sequence Number: 8719631
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: (01)00813024011255(17)260430
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: 04/30/2026
• Device Model Number: 106128
• Device Catalogue Number: 106128
• Device Lot Number: 10412270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2024
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2024
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White