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

Model Number 106531US

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2021

Event Type  malfunction  

Event Description

Related manufacturer report number 2916596-2021-02047.It was reported that the patient was home alone and controller screen went blank and white.The patient called the center and was instructed to not take any action and wait for further instructions for a controlled controller exchange.The patient reported no alarms during this period and that the green circle was illuminated indicating the pump was running.The patient was not experiencing any symptoms and seemed stable.The patients neighbor went to check on patient and the patient was found unconscious with percutaneous lead disconnected from controller and backup controller was found nearby.The red heart on the system controller was illuminated at this time.The patient was taken to the local hospital where the controller was swapped out for the backup.The pump started back up but low flow volumes were noted.The patient never regained consciousness and passed away on (b)(6) 2021.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the ¿controller screen went blank and white¿ was confirmed with the submitted reference photo.The submitted reference photo (controller) did captured an lcd display screen with no information with both pump running symbols illuminated.A root cause of the reported event could not be determined through this evaluation.Additional information communicated on 28jun2021 indicated the patient¿s family has an intention of returning the equipment for an evaluation; however, the time frame is unknown.The system controllers has not yet been retrieved.All available information for conducting this investigation was collected and no additional follow-up attempts will be performed.To date, the system controller (serial # (b)(6)) associated with the event was unavailable for an evaluation.The complaint file will close accordingly and will be reopened if pertinent information is received.Device history record indicated the device was manufactured in accordance to mfg and qa specifications.System controller (serial # (b)(6)) was shipped to the customer on 10may2020.Heartmate 3 patient handbook, cautions the users to ¿call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment.Your hospital contact can check the equipment and order replacements, if needed.Do not try to repair anything yourself.¿ under section 5 ¿alarms and troubleshooting¿, all alarm conditions are addressed including ¿driveline disconnected¿ alarms.1.Immediately reconnect the driveline to the system controller and move the driveline safety lock on the system controller to the locked position.(see page 33.) it may take up to 10 seconds for the pump to start.2.Check that the modular in-line connector is secure.3.If alarm persists after reconnecting the driveline, press any button on the system controller to potentially resolve.4.If driveline is connected and alarm persists, replace the system controller with a programmed backup system controller.See page 63.5.Immediately call hospital contact if steps 1¿3 do not resolve the alarm.In section 2, under ¿the system controller self test¿, the system controller self test is loud and bright.All of the lights, symbols, and sounds come on and ¿self test¿ appears on the screen.Also, under ¿how your heart pump works¿, covers replacing the running system controller with a backup controller.Important warning information associated with the system controller exchange.Important! do not attempt to change your system controller without having a trained, competent caregiver at your side to assist.Follow all alarm instructions, including calling the hospital if instructed.Heartmate 3 instructions for use ¿replace any equipment or system component that appears damaged or worn¿.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11735035
• MDR Text Key: 247703361
• Report Number: 2916596-2021-02048
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/26/2023
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7463402
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 66