Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Thoratec HeartMate 3 LVAS Kits [Model Number: 106524INT] [HKMD Number: 180052].
According to the TGA, the manufacturer is notifying customers that there have been complaints of blood leaking out of the left ventricle or air entering the left ventricle or Left Ventricle Assist Device (LVAD) which are attributed to a leak path at the seal interface between the HeartMate 3 Left Ventricle Assist System (LVAS) inflow cannula and the titanium apical cuff.
The manufacturer’s investigation determined that in certain instances, routine manipulation of the pump or internal fluid pressures during implantation can result in a compressed sealing ring on one side, leading to a leak path on the opposite side.
Potential harms due to this problem are extended surgery time, bleeding, haemorrhage, right heart failure, air embolism, or potential death from haemorrhage or air embolism.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00196-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 Mar 2024