MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER, INT; LVAD SYSTEM CONTROLLER

Model Number 106531INT

Device Problem Circuit Failure (1089)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

Approximate age of device ¿ 7 months.The reported event of a damaged fuse after switching system controllers can be confirmed.The evaluation of the returned system controller revealed a compromised printed circuit board (pcb) component (open fuse).As a result, the system controller activated a driveline power fault alarm; however, the pump support was not affected and the system controller successfully operated a test pump.Visual inspection of the system controller revealed a burn mark inside the driveline connector.The open fuse was successfully replaced and the system controller operated as intended with no active alarms.A full functional test was performed and the system controller passed all test steps.The system controller operated for extended period of time while connected to a mock circulatory loop with no adverse events or alarms noted.The data log file was successfully retrieved from the system controller and revealed low power advisory and power cable disconnect alarms followed by a driveline disconnect alarm.A driveline power fault alarm accompanied by an open fuse detection was recorded.The next entries indicated that the system initiated operation at the desired set speed with a driveline power fault alarm active.The driveline was disconnected and one minute later, both power cables were disconnected from the external power.In conclusion, the damaged fuse and the driveline power fault alarm was a result of an incorrectly inserted driveline (180 degrees).A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that the system controller was replaced due to a yellow wrench alarm.The patient was asymptomatic.The system controller reportedly had a damaged fuse, probably from the patient trying to swap the system controller.No additional information was provided.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER, INT
• Type of Device: LVAD SYSTEM CONTROLLER
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8082601
• MDR Text Key: 127537837
• Report Number: 2916596-2018-05118
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Model Number: 106531INT
• Device Catalogue Number: 106531INT
• Device Lot Number: 6255150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2016
• 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 Outcome(s): Required Intervention