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

Model Number 106531US

Device Problem Insufficient Information (3190)

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

Event Date 06/26/2022

Event Type  malfunction  

Manufacturer Narrative

The reported event of a yellow wrench advisory (controller fault) alarm was not confirmed.A review of the log file spanned approximately 11 days (b)(6) 2022 ¿ (b)(6) 2022 per the timestamps).There were no fault alarms related to the system controller operation presented in the log file.The driveline was disconnected on (b)(6) 2022 at 03:42 - 03:43 for a controller exchange.No other notable alarms were active in the log file.The returned system controller, serial (b)(4), was functionally tested and found to function as intended.The provided information indicated that the patient noted a yellow wrench alarm on the controller that resolved after the controller was exchanged.However, when the patient entered the clinic, the controller was plugged in for troubleshooting, but no fault alarms were noted.No pictures or additional documents related to the reported event were provided to this complaint.As a result, this analysis cannot conclusively determine a root cause for the reported event.The device history records were reviewed and the records revealed the controller (b)(4) was manufactured in accordance with mfg and qa specifications.The system controller was shipped to the customer on 27 dec 2021.Heartmate 3 instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿ explains how to properly interpret and troubleshoot all alarms.Heartmate 3 instructions for use section 8 ¿ ¿equipment storage and care¿ and heartmate 3 patient handbook section 5 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.The manufacturer is closing the file on this event.

Event Description

It was reported that a yellow wrench alarm was noted on the patient's system controller.The patient underwent a controller exchange successfully while at home.When the patient brought their controller to the clinic it was connected to the power module for interrogation and no "fault" alarms were listed.

• 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: 15078986
• MDR Text Key: 303092073
• Report Number: 2916596-2022-12056
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 8239751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• 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?: Yes
• Date Device Manufactured: 11/06/2021
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White