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	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that during preparation of the heartmate 3 pump implantation, the backup battery in the system controller alerted "backup battery fault alarm".The alarm would not clear after attempting to disconnect and reconnect backup battery, therefore it was replaced.Exchanging the backup battery resolved the backup battery fault alarms.
Additional Manufacturer Narrative
Manufacturer¿s investigation conclusion: the reported event of a backup battery fault alarm was confirmed via product testing.A backup battery fault alarm was triggered when the backup battery, serial number (b)(6), installed in a test controller on (b)(6) 2024 due to f34.When disconnecting both power cables the backup battery could not provide power the pump and the only feature still active was an audible alarm sound.The backup battery was opened and the fuses on the printed circuit board were measured.Measuring components u10 and d58 were an open loop indicating f4 was damaged.The tabs of the backup battery were damaged to measure the actual fuse.The fuse (f4) was measured as an open loop.No other notable events were observed.The system controller related to the event was not returned for analysis, but the 11v backup battery was returned.Per additional information, the alarm resolved upon exchanging the backup battery.The root cause of the reported event was determined to be component failure of fuse f4.The device history record for the 11v backup battery (serial number (b)(6)) was inspected on 2jul2024.No deviations from manufacturing or qa specifications were shown from the backup battery.Heartmate 3 instructions for use (rev.C) section 7 entitled ¿alarms and troubleshooting¿ and heartmate 3 patient handbook (rev.D) section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including backup battery fault alarms.Heartmate 3 instructions for use (rev.C) section 8 entitled ¿caring for the equipment¿ and heartmate 3 patient handbook (rev.D) section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.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.
Additional Manufacturer Narrative
Manufacturer¿s investigation conclusion: the reported event of a backup battery fault alarm was confirmed via product testing.A backup battery fault alarm was triggered when the backup battery, serial number (b)(6), installed in a test controller on (b)(6) 2024 due to f34.When disconnecting both power cables the backup battery could not provide power the pump and the only feature still active was an audible alarm sound.The outer casing of the backup battery was removed to inspect the battery¿s internal components.Circuit analysis performed on the battery revealed component d52 (zener diode) was shorted from pin 2 to ground, resulting in the lcs_ctrl signal shorting to ground.This resulted in the backup battery fault alarm being active on the controller.The system controller related to the event was not returned for analysis, but the 11v backup battery was returned.Per additional information, the alarm resolved upon exchanging the backup battery.The root cause of the reported event was determined to be a damaged circuit board component (d52) on the backup battery; however, the cause of how it became damaged could not be conclusively determined through this analysis.A manufacturing analysis task was opened to further investigate this issue.The device history record for the 11v backup battery (serial number (b)(6) was inspected on (b)(6) 2024.No deviations from manufacturing or qa specifications were shown from the backup battery.Heartmate 3 instructions for use (rev.C) section 7 entitled ¿alarms and troubleshooting¿ and heartmate 3 patient handbook (rev.D) section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including backup battery fault alarms.Heartmate 3 instructions for use (rev.C) section 8 entitled ¿caring for the equipment¿ and heartmate 3 patient handbook (rev.D) section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.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: 20426047
• Report Number: 2916596-2024-06535
• Device Sequence Number: 18107928
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: (01)00813024011255(17)260513
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/18/2025

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: 05/13/2026
• Device Model Number: 106128
• Device Catalogue Number: 106128
• Device Lot Number: 10412718
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 11/11/2024; 01/27/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/12/2024; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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: 33 YR
• Patient Sex: Male
• Patient Weight: 72 KG