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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00750-1
Product Name/Description HeartMate 3 Left Ventricular Assist System (LVAS)

Catalogue Number: 106524INT – LVAS KIT, HM 3

Serial Number: MLP-002965

Supplied through the Special Access Scheme
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 14/06/2017
Responsible Entity St Jude Medical Australia Pty Ltd
Reason/Issue Abbott has identified reports (1.29% incident rate, with no patient injuries) of errors in communication between the System Controller and pump of the HeartMate 3 LVAS. There is the potential for a communication error which triggers a communication fault advisory alarm on the System Controller. Abbott has traced the issue to manufacturing variances that could lead to crystallisation formation, which may then disrupt communication between the pump and the System Controller.

The LVAS has a redundant communication line so a complete loss of communication between the System Controller and pump will only occur if both lines are affected. The LVAS has an on-board diagnostic system that monitors for these conditions several times per second. In this rare situation, the LVAS pump will continue to operate as programmed after the point communication is lost. Communication between the System Controller and pump, including the interface to make pump operating changes, is no longer feasible.
Recall Action Hazard Alert
Recall Action Instructions For loss of a single communication line (Driveline COM Fault), accompanied by an advisory alarm, the Driveline COM Fault advisory alarm can be manually silenced on System Controller for 4 hrs with 1 functioning communication line or permanently silenced via System Monitor.

For loss of both communication lines (COM Fault), noted by presence of COM Fault advisory alarm, the COM Fault advisory alarm can be manually silenced on System Controller for 4 hrs or via System Monitor for 24 hrs. The COM Fault advisory alarm will display even if Driveline COM Fault advisory alarm is permanently silenced.

Remind patients to contact their VAD Coordinator in the event an advisory alarm appears on their System Controller.

Physicians managing patients subject to an Advisory COM Fault alarm should determine patient care recommendations based on each clinical case.

This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information 1800 739 312 - Abbott Technical Services