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

Model Number 106531US

Device Problems Alarm Not Visible (1022); Improper or Incorrect Procedure or Method (2017); Communication or Transmission Problem (2896); Insufficient Information (3190)

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

Event Date 07/16/2023

Event Type  malfunction  

Manufacturer Narrative

Related regulatory reference report # 2916596-2023-05413.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient was instructed to change the system controller due to battery connection alarms.Once the controller was exchanged, everything appeared to be normal until around 10:30 am when the patient had a communication fault alarm.The alarm repeated an hour later.The system controller was later unable to pull up these alarms, pulsatility index (pi) parameters, and power values.The date and time on the system controller was not set.The log files showed an internal time base controller fault that indicated that the clock used was corrupt.The system controller was exchanged again.There were no further alarms after the exchange.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of an intermittent communication fault alarm and the pump parameters not being displayed on the controller¿s screen can be confirmed.During the evaluation of the returned system controller, serial number (b)(6), an intermittent call hospital contact/controller fault alarm accompanied by a yellow wrench symbol was reproduced.In addition to the alarm there was a compromised communication between the controller and the system monitor and the controller and the pump; however, the pump support was not affected.The log files were retrieved and the data contained in the event log file revealed that the system operated at the set speed with active controller internal fault and controller clock corrupt alarms.The alarms were associated with internal error codes (f28) timebase and (f49) clock_invalid.In addition to these alarms, there were some entries where the communication with the pump was lost (loss_of_lvad_comm) and a controller reset was captured (reset_controller).The events recorded in the periodic log file revealed that the system operated at the set speed with the controller¿s clock being corrupted.Further evaluation of the system controller isolated the problem to the printed circuit board (pcb); however, the specific root cause was not able to be identified.The company will continue to monitor and track similar events.The device history records were reviewed and the records revealed the system controller was manufactured in accordance with mfg and qa specifications.Heartmate 3 patient handbook under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use, under section 7 ¿alarms and troubleshooting¿ explain all alarms and the proper actions to take if the alarms cannot be resolved.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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The alarms resolved following the system controller exchange.Related mfr # 2916596-2023-05413.

• 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: 17371670
• MDR Text Key: 319511291
• Report Number: 2916596-2023-05414
• 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: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• 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: 8315094
• 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: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2022
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White