MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 11 VOLT LI-ION BACKUP BATTERY; VENTRICULAR (ASSISST) 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	12/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a backup battery fault alarm was confirmed via evaluation of the returned backup battery (serial number: (b)(4) ).The battery was returned unremarkable condition.The backup battery was connected to a test system controller, system monitor, and power module, and a backup battery fault was active, confirming the reported event.The outer casing of the backup battery was removed to inspect the battery¿s internal components.Circuit analysis performed on the battery revealed an atypical lcs_ctrl voltage output; this output corresponds to pin 9 on the backup battery.Further analysis of the battery revealed that component d52 (zener diode) was shorted from pin 2 to pin 3, resulting in the lcs_ctrl signal shorting to ground.This resulted in the backup battery fault alarm being active on the controller and the inability to charge the backup battery fully.The root cause of the reported event was determined to be a damaged circuit board component on the backup battery; however, the cause of how it became damaged could not be conclusively determined through this analysis.Battery inspection data was reviewed for the 11v backup battery, serial number (b)(4), revealing that the battery passed all inspection testing.Customer order was shipped on (b)(6) 2021.Heartmate iii patient handbook under section 5 ¿alarms and troubleshooting¿ and heartmate iii instructions for use (ifu) under section 7 ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including the backup battery fault alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate iii instructions for use (ifu) section 2 "system operations" explains how to replace the system controller backup battery.Section 5 ¿surgical procedures¿, explains how to install the backup battery in the system controller.Heartmate iii patient handbook cautions 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.
Event or Problem Description
It was reported that the patient was seen in the clinic for a routine backup battery exchange due to expiration.The new backup battery out of box triggered a backup battery fault alarm.This happened with 2 additional out of box backup batteries.The fourth backup battery installed worked without issue.Additional information reported that 2 of the batteries had bent pins out of box.Related manufacturer reference number: 2916596-2022-00487 & 2916596-2022-00486.

• Brand Name: HEARTMATE 11 VOLT LI-ION BACKUP BATTERY
• Common Device Name: VENTRICULAR (ASSISST) 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13345205
• Report Number: 2916596-2022-00489
• Device Sequence Number: 11174525
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: 00813024011255
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2022

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: 08/06/2023
• Device Model Number: 106128
• Device Catalogue Number: 106128
• Device Lot Number: 8143509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• 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: 01/24/2022
• Initial Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2021
• 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: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White