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

Model Number 106531US

Device Problem Electrical Power Problem (2925)

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

Event Date 03/03/2022

Event Type  malfunction  

Event Description

It was reported that patient experienced a backup battery fault starting on (b)(6) 2022 at 11:36 which resolved after the controller was powered down and the patient performed an independent exchange on (b)(6) 2022 at 15:56.Prior to the controller exchange troubleshooting was performed: the backup batteries were exchanged, cables were inspected, and the clock was synched.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a backup battery fault alarm was confirmed via the log file review.The log files spanned approximately 2 days ((b)(6) 2022, (b)(6) 2022, and from (b)(6) 2022 to (b)(6) 2022 per the timestamp).A backup battery fault alarm activated on (b)(6) 2022 at 11:36 due to a load test failure.The backup battery failed the load test due to the loaded voltage being lower than expected threshold comparison to the unloaded voltage.Prior to the failed load test, the controller passed multiple load tests without issue.The alarm remained active until the controller was powered down on (b)(6) 2022 at 15:56.The driveline was disconnected from the controller on (b)(6) 2022 at 15:55 for a controller exchange.The controller was briefly connected to a power source on (b)(6) 2022 and (b)(6) 2022 without connecting to a driveline.No other notable alarm was observed.The hm3 system controller, serial (b)(4), was not returned for analysis.A root cause of the reported event was not determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.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.Heartmate iii instructions for use section 7-¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot alarms including backup battery fault.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: 15111822
• MDR Text Key: 304598661
• Report Number: 2916596-2022-12472
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7379106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2019
• 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
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 139 KG