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); Electrical Power Problem (2925)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

It was reported that controller fault alarms, clock not set, and replace backup battery alarms were observed on the backup controller at a clinic appointment on (b)(6) 2022.A new ebb was placed but the alarms did not clear.The patient was given a new backup controller and no further alarms were observed.

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 events of controller fault and clock not set alarms, and replace backup battery message was confirmed via analysis of the submitted log file and/or evaluation of the returned heartmate 3 system controller (serial number: (b)(6)).The log file contained relevant events between dates 23mar2021 and 04may2022 per the timestamps; the log file captured dates 01jan2000 and 28jan2000 when the clock was not set.It was reported that the log file was associated with the patient¿s backup controller, which is consistent with the data observed.Clock not set alarm were observed throughout the log file due to the controller¿s clock resetting multiple times.The first instances of the alarm were cleared when the controller¿s clock was set to the current date and time; however, the last instance of the alarm did not resolve throughout the log file.The clock resetting may be associated with the backup battery being uninstalled or the backup battery becoming depleted.Intermittent controller fault alarms associated with lcd communication fault activated from 04may2022 at 11:51:27; the alarm activated intermittently throughout the remainder of the log file.There were no other notable alarms on the log file.The alarms did not affect the patient as the driveline was not connected throughout the log file.It was noted that the system controller backup battery was uninstalled when the controller was returned; the backup battery was installed without any issues.The controller was connected to a mock circulatory loop and the reported alarms were observed.The clock not set alarm was associated with the backup battery being uninstalled from the controller; the alarms resolved without any issues when the clock was set on the system monitor.A replace backup battery message was observed on the system monitor due to the backup battery being close to the expiration date; this message does not indicate any issues with the products and the message did not result in an alarm activating.Review of the log file revealed that the controller fault alarm was associated with an lcd communication fault that is coincident with a bitmap software issue.The bitmap was reloaded on the controller and the controller fault alarm resolved.The controller was then functionally tested and passed without any issues.The root cause of the reported controller fault and clock not set alarms could not be conclusively determined through this analysis.The root cause of the replace backup battery message was determined to be the backup battery being close to expiring.Heartmate 3 patient handbook (rev.C) section 5, entitled ¿alarms and troubleshooting¿, and heartmate 3 instructions for use (rev.C) section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible), including the controller fault and clock not set alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate 3 patient handbook (rev.C) section 6, entitled "caring for the equipment", describes how to care for and clean all equipment, including the system controller.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvad.Heartmate 3 instructions for use (ifu) (rev.C) section 4, entitled "system monitor", explains how to set the system controller clock using the system monitor.The heartmate 3 instructions for use (ifu) (rev.C) section 2, entitled ¿system operations¿, instructs the user on how to properly exchange the system controller backup battery.Section 5, entitled ¿surgical procedures¿, also explains how to properly install the backup battery in the system controller.This section also states ¿be aware that installing an 11 volt lithium-ion backup battery may prompt a system controller clock not set advisory alarm on the system monitor¿.Heartmate 3 instructions for use (ifu) (rev.C) explains how to how to view the backup battery information on system monitor, including the manufacture date and the number of months until the backup battery needs to be replaced.Section 2 ¿system operations¿ under ¿system controller backup battery power¿ informs the user that the backup battery has a limited lifespan of 36 months from the manufacture date.Heartmate 3 patient handbook (rev.C) 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.The device history records were reviewed and the records revealed that the heartmate 3 system controller, serial number (b)(6) was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 system controller was shipped to the customer on 23jun2020.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: 14754189
• MDR Text Key: 298043178
• Report Number: 2916596-2022-11623
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/03/2023
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7529456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2020
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White