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

Model Number 106531US

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 06/07/2022

Event Type  malfunction  

Event Description

It was reported that the patient showed up with controller fault alarms.Log files captured constant lcd communication faults on (b)(6) 2022.The controller was exchanged and the alarms resolved.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a controller fault alarm was confirmed.The provided log file, as well as a log file extracted from the controller, were reviewed.The data collectively spanned approximately 3 days (04jun2022 ¿ 07jun2022 per timestamp).The pump maintained speeds above the low speed limit while connected to the driveline.A controller fault alarm correlating to an lcd communication error was observed on 07jun2022 at 00:34.The alarm remained active throughout the remainder of the data, indicating that the controller¿s lcd board was not receiving information properly.The returned system controller (serial number (b)(6) was functionally tested, and this fault condition was reproduced.The controller operated a mock loop as intended despite the controller fault.The controller¿s lcd/bitmap software was reuploaded, and further atypical events were unable to be reproduced after this point, indicating that the root cause of the reported event was the controller¿s lcd/bitmap software becoming corrupt.However, the root cause of how the software became corrupt was unable to be conclusively determined.Review of the device history record for system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate 3 patient handbook (rev.D, section 5 ¿alarms and troubleshooting) instructs users on how to resolve alarms that sound from their system controller, including alarms associated with controller fault conditions.The heartmate 3 patient handbook (rev.D, section titled "emergency contact list") cautions 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: 14805629
• MDR Text Key: 300231814
• Report Number: 2916596-2022-11658
• 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,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/20/2023
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7811844
• 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: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2020
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 100 KG