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

Model Number	106128
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing report number: 2916596-2021-06813.It was reported that the patient experienced a "replace system controller" alarm at home.They then presented themselves to the clinic for a system controller exchange.Additional information revealed the customer's report of a controller fault alarm following driveline repair as well as evidence of internal driveline damage; a separation of the wire ribbon within the controller.A review of the log files revealed a momentary replace controller event on (b)(6) 2021 at 1032 which was associated with a backup battery test circuit fault.Additionally, they reported the controller passed another self-test in the clinic.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the event of a backup battery fault alarm was able to be confirmed.The 11v backup battery (serial number: (b)(4)) was returned for analysis, and a log file was submitted for review another was downloaded for review.A review of the log files showed events spanning approximately 4 days ((b)(6) 2017, (b)(6) 2021 ¿ (b)(6) 2021 per timestamp).The events recorded on (b)(6) 2017 showed that the controller still had the manufacturing settings and the driveline was never connected.There were no notable alarms active in the log file pertaining to the reported event.The 11v backup battery underwent functional testing and did not pass.The battery was opened to inspect the printed circuit board (pcb).Circuit analysis was performed and it was found that the voltage leading into component u1 was normal, however, there was no voltage coming out of the component.The circuit components around and including u1 are located on the backside of the pcb and are inaccessible; therefore, no further testing was able to be conducted; however, the issue was isolated to a loss of signal from u1.The root cause of the reported event was unable to be conclusively determined through this investigation.Incidental findings: damaged components.Heartmate ii instructions for use (rev.C) section 7 entitled ¿alarms and troubleshooting¿ and heartmate ii patient handbook (rev.C) section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including backup battery fault alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate ii instructions for use (rev.C) section 2 entitled ¿system operations¿ states how to replace the system controller backup battery.Heartmate ii instructions for use (rev.C) section 5 entitled ¿surgical procedures¿ states how to install the backup battery into 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.The device history records were reviewed for the 11v backup battery (serial number: (b)(4)) and was found to pass all manufacturing and qa specifications before being shipped to the customer on 29aug2017.No further information was provided.The manufacturer is closing the file on this event.

• 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 Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13266415
• Report Number: 2916596-2022-00294
• Device Sequence Number: 17333642
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: 00813024011255
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/17/2022

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: 07/14/2020
• Device Model Number: 106128
• Device Catalogue Number: 106128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• 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: 01/06/2022
• Initial Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2017
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White