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

Model Number 106524US

Device Problems Malposition of Device (2616); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient had some low flow alarms and was asymptomatic.The patient was able to increase the pump speed in hemodynamics, so the institutional physician was considering raising the pump speed.The facility plan was to update the patient's controller's low flow software if the low flow alarm didn't improve after increasing the pump speed.Facility medical engineers were also concerned that there were few events displayed on the system monitor during the analysis of the log technical services observed low flows with high pi readings, which seemed to be physiological in nature.It was reported that the cause of the low flow was not clearly identified but the patient's body size and the inflow cannula position were possible causes.Low flow alarms stopped after increasing the speed, and the clinical team would confirm the resolution of those and the pi events at the next visit.The device was reportedly operating as expected.

Manufacturer Narrative

Manufacturer investigation conclusion: analysis of the log files that were provided by the account confirmed low flow events; however, a specific cause could not conclusively be determined through this evaluation.The account submitted a log file for review.The system controller event log file contains data from (b)(6) 2020 at 16:29:09 through (b)(6) 2020 at 15:08:34.Intermittent low flow events were captured throughout the log file from (b)(6) 2020 at 16:29:09 through (b)(6) 2020 at 15:08:29.Per design, when the flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.A 10-second delay is imposed between the detection of the low flow status and the activation of the associated audio and visual indicators on the system controller.Some of the events lasted over 10 seconds, and low flow alarms were flagged.The pump appeared to function as intended.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 02jul2019.The heartmate 3 (hm3) instructions for use (japan) is currently available.The section entitled ¿system monitor¿ explains that the low flow hazard alarm is triggered when pump flow is less than 2.5 lpm, the pump has stopped, the pump is not operating properly, or the driveline is disconnected from the system controller.Changes in patient conditions can result in low flow, such as hypertension.The section entitled ¿alarms and troubleshooting¿ explains all system alarms and the recommended actions associated with them.This document also explains that pulsatility index events are assumed by the system during cases when there are sudden and substantial changes in the pulsatility index.These events are also referred to as pi events, and may be initiated for reasons other than true pi events.Some reasons include sudden changes in a patient¿s volume status, arrhythmias, sudden changes in power, and sudden changes in pump speed.If the system detects a pi event, the pump speed automatically drops to the low speed limit and slowly ramps back up at a rate of 100 rpm per second to the fixed speed setpoint.This drop in speed is accompanied by a reduced pump flow.There are no audible alarms with a pi event.The hm3 lvas patient handbook (japan) is also available.The section entitled "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document patient the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11066290
• MDR Text Key: 223453121
• Report Number: 2916596-2020-06116
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7397112
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1