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 Administration (TGA) has posted a medical device safety alert concerning Thoratec Switzerland GmbH CentriMag Console (2nd Generation CentriMag Primary Console) [Model numbers: 201-30300, 201-90401, 201-90701] [HKMD No.: 140453].
According to the TGA, internal testing showed that due to a component change, the CentriMag Console may not conform to the IEC 61000-4-5 standard. If subjected to a power surge above 1.8kV and up to 2.0 kV, the CentriMag Console may shut down completely without alarm. A power surge may be caused by, including, but not limited to the following: lightning strike, unregulated power switching, or faulty equipment. Pumping would cease and the patient would have to be switched to a backup.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00390-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 May 2024