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

Model Number 106531US

Device Problems Disconnection (1171); Improper or Incorrect Procedure or Method (2017); Electrical Power Problem (2925); Complete Loss of Power (4015)

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

Event Date 11/08/2023

Event Type  malfunction  

Event Description

It was reported that the patient's controller that had obvious wear on the power sources had no history on it, except that the emergency backup battery (ebb) was used multiple times and the ebb needed to be replaced.

Manufacturer Narrative

Related pump manufacturer report number: 2916596-2023-08008.Related other controller manufacturer report number: 2916596-2023-08009.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 the clock not being set, and multiple alarms were confirmed during evaluation of the returned heartmate 3 system controller (serial number (b)(6)).Upon arrival, a log file was downloaded for review.The clock was not set properly throughout the log file, and the recorded information spanned 3 dates (23apr2000, 16mar2001, and 04may2001 per timestamp).From 6:27 to 6:33 on 23apr2000, the controller appeared to be in patient use.Frequent low power hazard and power cable disconnect alarms were observed during this timeframe while the controller was connected to battery power.These alarms activated due to the relative state of charge (rsoc) of either power cable fluctuating below the designed alarm thresholds.These alarms did not impact the ability of the controller to operate the pump, as the pump maintained a speed above the low-speed limit while the driveline was connected.The driveline was disconnected from 6:31:34 to 6:31:40 on 23apr2000, which activated a driveline disconnect alarm and caused the pump to stop.The driveline was then reconnected at 6:31:40, and the pump returned to a speed above the low-speed limit within a few seconds.The driveline was disconnected again at 6:33:46, and was shut down shortly later at 6:42:12, which appears to be consistent with its exchange.No other notable events were observed throughout the data, and the controller was not put into patient use again.Although the clock was not properly set, the abnormal alarms, driveline disconnection, and controller exchange described on 23apr2000 do not appear to be related to the patient¿s passing on 08nov2023.When the controller was analyzed by abbott on 18jan2024, the clock of the controller was found to be set to 04may2001.Using the difference between the 23apr2000 and 04may2001 timestamps, it can be determined that the abnormal alarms, driveline disconnection, and controller exchange occurred sometime around 07jan2023.This controller then served as the patient¿s backup controller until the patient had passed away.During evaluation of the returned controller, abnormal alarms were not able to be reproduced.The system controller was found to be in unremarkable physical condition.The controller operated as intended throughout all testing procedures and was able to support a mock circulatory loop for an extended period of time without issue.The root cause of the clock being set could not be conclusively determined through this analysis.The root cause of the abnormal low power hazard and power cable disconnect alarms could not be conclusively determined through this analysis.The device history records were reviewed, and the records revealed that the system controller (serial number: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.Heartmate 3 patient handbook (rev.D) section 2 entitled ¿how your heart pump works¿ instructs users to regularly ensure that their driveline is connected and secured within the system controller, and to reconnect it immediately in the case that it becomes disconnected.Users are warned that the pump will stop running when the driveline is disconnected.Heartmate 3 instructions for use (rev.C) section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook (rev.D) section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including low voltage advisory/hazard, no external power, driveline disconnect, pump off, and controller clock not set alarms, and the actions to take if the issue does not resolve.The heartmate 3 patient handbook (rev.D - section 6 ¿caring for the equipment¿) describes how to properly care for and clean all equipment, including the system controller and its power cables.Heartmate 3 instructions for use (rev.C) section 2 ¿ ¿system operations¿ explains the operation of the system controller backup battery.If the original 11 volt lithium-ion backup battery exceeds its expiration date or if a backup battery fault alarm appears on the information display screen, the battery must be replaced.The patient handbook and the instructions for use caution 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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient passed away on (b)(6) 2023.The patient had been found down with frayed cords and alarms going off.There were red heart alarms and driveline disconnect alarms.The patient's sister reported seeing the patient via a video doorbell.The patient had reportedly gone into their bedroom, and it was assumed they were changing their batteries.Then the device could be heard alarming.It was unclear how long this was.The patient's ex-spouse eventually went in to check on the patient and at that time they had passed.The patient was brought to a hospital and the healthcare team did not know how to turn off the device.Technical services advised the customer on how to place controller in a sleep mode.The hospital reported that the patient's family had taken the system controller home with them.The patient's equipment was later returned to their original implanting center.This account noted that the patient was very non-compliant and had been lost to follow up for most of 2023.The account reported that one controller had obvious wear on the power sources and no history on it, except that the emergency backup battery (ebb) had been used multiple times and the ebb needed to be replaced.They reported that the second controller had multiple alarms which they believed were from (b)(6) 2023; however, the controller clock was not set so the alarms were showing from (b)(6).The observed alarms reportedly started as low voltage/connect to power source.Then, it went to pump off, low flow, and driveline disconnected.Related pump manufacturer report number: 2916596-2023-08008.Related controller manufacturer report number: 2916596-2023-08009.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18365922
• MDR Text Key: 331008539
• Report Number: 2916596-2023-08475
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 813024013235
• 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
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/07/2023
• Device Model Number: 106531US
• Device Lot Number: 7703404
• 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: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2020
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American