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

Model Number 106531INT

Device Problems Alarm Not Visible (1022); No Display/Image (1183); Insufficient Information (3190)

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

Event Date 02/02/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient heard an audible alarm with no information on the system controller.This was previously reported, and the battery clips were previously exchanged.The system controller was exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of an unidentified alarm coming from the system controller was not confirmed.There was no photos or log files submitted for review.System controller, serial (b)(6), was not returned for analysis.The provided information indicated that there was an audible alarm coming from the controller without any information displaying on the controller.It is unknown how long the alarm was active for and therefore could have resolved before the patient looked at the displayed message on the controller.The battery clips were exchanged without resolving the issue.The alarm resolved after the controller was exchanged.A root cause for the reported event cannot be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The patient handbook and instructions for use (ifu) also 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 3 ifu section 7-¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5-¿alarms and troubleshooting¿ explain how to troubleshoot all system controller alarms.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that on (b)(6) 2023, the patient heard an audible alarm with no information on the system controller.The battery clips were exchanged.On (b)(6) 2023, the patient experienced the problem again and heard an audible alarm with no information on the system controller.The system controller was exchanged which resolved the alarm.

• 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: 16592703
• MDR Text Key: 312008727
• Report Number: 2916596-2023-01634
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531INT
• Device Lot Number: 8644731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2022
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 85 KG