MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524INT

Device Problems Decreased Pump Speed (1500); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Sepsis (2067)

Event Date 05/22/2022

Event Type  Injury  

Event Description

It was reported that the speed was adjusted due to sepsis.The source of infection was bacteremia.It was no pump related.The infection was certified on (b)(6) 2022, but culture was not identified.The device operated as expected.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number: (b)(6), and the reported event could not conclusively be established through this evaluation.A specific cause for the patient's infection could not conclusively be determined through this evaluation.Furthermore, an analysis of the submitted log files confirmed low flow hazard alarms; however, a specific cause for this finding could not be conclusively established through this evaluation.Lastly, an analysis of the submitted log files confirmed low speed advisory alarms.The submitted system controller event log file contained data on (b)(6) 2022.The file captured low speed advisory alarms throughout the duration of the log file, due to the patient¿s speed being set lower than the low speed limit.Low flow hazard alarms were also observed throughout the duration of the file.The pump appeared to function as intended at the set speed.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 24feb2022.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this document lists sepsis, infection (local, driveline, pump pocket) as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 1 of the ifu provides an explanation of all pump parameters, including flow.Section 4 "system monitor" provides information about the pump flow display and the low flow hazard alarm.This section states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 liters per minute (lpm).The ifu explains that changes in patient conditions can result in low flow.This section also states that a low speed advisory alarm will appear if the fixed speed has been set 200 revolutions per minute (rpm) or more below the low speed limit.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.Care instructions in regard to preventing infection are provided in various sections of the ifu, including controlling infection.The heartmate 3 lvas patient handbook is also currently available.Section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document instructs the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.This document contains information about preventing infection.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 14956243
• MDR Text Key: 295487233
• Report Number: 2916596-2022-11859
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/02/2022
• Device Model Number: 106524INT
• Device Lot Number: 7948035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/19/2022
• Supplement Dates FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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 Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 84 KG