MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number 106531INT

Device Problems Electrical /Electronic Property Problem (1198); Electro-Static Discharge (2149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2022

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the system controller showed an internal fault after electrostatic discharge events.The system controller was exchanged with the backup controller.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported electrostatic discharge events were not confirmed; however, a controller fault alarm was confirmed via log file analysis.The heartmate 3 system controller (serial #: (b)(6) was returned for analysis, a log file was downloaded, and log files were submitted for review.The log files spanned approximately 10 days (28apr2022 ¿ 07may2022, 02jun2022 per timestamp).Events on 02jun2022 are from product testing at abbott.On 06may2022 at 21:01:48, a controller internal fault alarm activated associated with the boost voltage of the unit.The controller internal fault alarm persisted through the remainder of the log file until after the driveline was disconnected for a controller exchange.There were no other notable alarms in the log file related to the reported event.The system controller was tested and passed all stages of testing.The unit was able to operate as intended and was able to run on a mock loop for an extended duration without issue.The reported event was not reproduced.The root cause of the reported event was unable to be determined in this analysis.The device history records were reviewed and the records revealed the heartmate iii system controller (serial#: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.Heartmate iii instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5 ¿ ¿alarms and troubleshooting¿ explains how to properly interpret and troubleshoot all alarms, including controller fault alarms.Heartmate iii instructions for use section 8 ¿ ¿equipment storage and care¿ and heartmate iii patient handbook section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment.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: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14361555
• MDR Text Key: 291631478
• Report Number: 2916596-2022-10891
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/06/2023
• Device Model Number: 106531INT
• Device Lot Number: 7801050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1