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); Complete Loss of Power (4015)

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

Event Date 12/25/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacture¿s investigation conclusion: the reported event of the patient not hearing the alarms associated with the pump stop was not confirmed.The reported events of a pump stop and no external power alarms were confirmed via analysis of the submitted log files.The controller event log files contained approximately 19.5 days of data combined (25dec2022, 01jan2000 ¿ 15jan2000, 08jan2023 ¿ 11jan2023 per the timestamp).The log file captured a low voltage hazard alarm on 25dec2022 at 5:57:24 due to the 14v batteries depleting below the low voltage threshold; this was the first event captured in the log file.A no external power alarm then activated at 6:00:02 due to the batteries fully depleting.A controller fault alarm then activated at 7:52:18 and a lvad off alarm activated on 7:52:21 due to the system controller backup battery fully depleting.The controller turned off shortly after 7:53:10.The log file then captured the controller being reconnected to the mobile power unit (mpu) and the pump resuming operation at the set speed.It should be noted that the clock was reset to the default time stamp due to the 14v batteries and the backup battery fully depleting.The log file captured dates 01jan2000 to 15jan2000 when the controller¿s clock was not set.A clock not set alarm was active when the clock was not set.The log files captured the clock being set to the correct date and time on 08jan2023 at 10:54:00 and the clock not set alarm resolved.No external power alarms were also active from 02jan2000 at 8:18:18 to 13jan2000 at 6:16:22 and from 09jan2023 at 8:24:30 to 13jan2023 at 8:58:02 due to both power cables being disconnected at the same time; the alarm resolved when the controller was reconnected to external power each time.The system controller backup battery supplied power to the system and pump operation was not affected during the further losses of external power.Aside from the pump stop noted on 25dec2022, the pump maintained a speed above the low speed limit throughout the log file.Multiple requests for additional information were made to determine if the system controller was alarming appropriately and the cause of the patient not hearing the alarms; however, no response was received.The heartmate 3 system controller serial number: (b)(4) was not returned for evaluation.It was reported that the patient was asleep during the reported pump stop event.The root cause of the patient not hearing the controller alarms could not be conclusively determined through this analysis.The root cause of the pump stop event was determined to be the 14v batteries and backup battery fully depleting.The root cause of the reported no external power alarms not associated with the pump stop was determined to be a user error in which both power cables were disconnected from external power at the same time.Heartmate 3 patient handbook section 5, entitled ¿alarms and troubleshooting¿, and heartmate 3 instructions for use (ifu) section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible), including the pump stop, clock not set, backup battery fault, no external power, low voltage hazard and power cable disconnect alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate 3 instructions for use and heartmate 3 patient handbook section 3, entitled ¿powering the system¿, explain the various ways to power the heartmate 3 lvas, and how to properly exchange power sources.It also states that at least one system controller power cable must be connected to a power source at all times and informs the user not to rely on the controller's backup battery, as it will only power the pump for a limited amount of time and the pump will stop.This section explains that a pair of new, fully charged 14v batteries provides up to 17 hours of support and explains how to check the battery life by using the on-battery power gauge button.Heartmate 3 instructions for use section 2, entitled "system operations", explains how to replace the system controller and how to replace the system controller backup battery.Section 5, entitled ¿surgical procedures¿, also explains how to install the backup battery in the system controller.Heartmate 3 instructions for use (ifu) section 6, entitled ¿patient care and management¿, states that the system controller must be connected to the power module or the mobile power unit during sleep or any time when sleep is likely.The patient may not be able to hear alarms while sleeping on battery power.The heartmate 3 patient handbook cautions the user 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)(4), was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 system controller was shipped to the customer on 11sep2018.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient's device experienced a pump stop on 25dec2022 because the external and internal battery was allowed to drain completely while the patient was sleeping.This caused the controller clock to reset.On 01jan2023, the patient received two notifications that the pump was off.The patient did not recall hearing an alarm and has not had any issues.There was a no external power alarm on 13jan2023.

• 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: 16277221
• MDR Text Key: 308937965
• Report Number: 2916596-2023-00337
• 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
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/19/2021
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 6566028
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2018
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 78 KG