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

Model Number 106531US

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

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

Event Date 05/23/2023

Event Type  malfunction  

Event Description

It was reported that controller was exchanged due to damage to primary controller data cable from shutting in a door.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a controller exchange due to the primary controller data cable being shut in a door was not confirmed.The heartmate 3 system controller (serial number (b)(6)) was not returned for analysis.Additionally, there were no log files, photos, or any other supporting documentation that would confirm the reported event.Provided information stated that the patient had a controller exchange because the data cable was shut in a door, resulting in a faulty data cable and the controller will not be returned, the root cause of the reported event was unable to be conclusively determined through this analysis; however, per provided information, the controller cable was shut in a door.Incidental finding revealed fluid ingress in the power cable, via submitted photo.Heartmate 3 instructions for use (rev.C) section 7 entitled ¿alarms and troubleshooting¿ and heartmate 3 patient handbook (rev.D) section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including power cable disconnect and low voltage alarms.The heartmate 3 patient handbook (rev.D - section 6 "caring for the equipment) describes how to care for and clean all equipment, including the heartmate 3 system controller and its power cables.The heartmate 3 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, and the records revealed the heartmate 3 system controller (serial#: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18678440
• MDR Text Key: 336057440
• Report Number: 2916596-2024-00891
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531US
• Device Lot Number: 8167919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2021
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American