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

Model Number 106531

Device Problems Disconnection (1171); Device Difficult to Setup or Prepare (1487)

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

Event Date 03/26/2022

Event Type  malfunction  

Manufacturer Narrative

Patient death is captured under manufacturer report number 2916596-2022-11834.Manufacturer's investigation: the reported events of the driveline being difficult to connect to the system controller, as well as atypical alarms, were not confirmed, as the system controller (serial number (b)(4)) was not returned for analysis.No log files were associated with the reported event.The cause and nature of the reported alarms, as well as the cause of the patient¿s driveline initially becoming disconnected, were unable to be determined.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for the system controller, serial number (b)(4), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate 3 patient handbook (rev.D, ¿how your heart pump works,¿ under sub-section titled "connecting the driveline to the system controller,") addresses the proper steps for connecting the driveline to the system controller.The heartmate 3 patient handbook (rev.D, ¿alarms and troubleshooting¿) instructs users on how to resolve all alarms that sound from their system controller.The heartmate 3 patient handbook (rev.D titled "emergency contact list") 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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient's wife heard the patient's device alarming in the early morning.She noted the driveline was disconnected from the controller.She tried to reconnect the driveline and struggled.Emergency medical services (ems) began cardiopulmonary resuscitation (cpr) but the patient was not able to be revived.The patient passed away due to cardiac arrest.Related manufacturer report number: 2916596-2022-11834.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• MDR Report Key: 14875380
• MDR Text Key: 302704590
• Report Number: 2916596-2022-12037
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2022

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: 05/24/2021
• Device Model Number: 106531
• Device Lot Number: 6525843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 84 KG