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.
Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its HeartWare Ventricular Assist Device (HVAD). [HKMD No.: 180485].
The manufacturer is informing users of upcoming updates to the HVAD system Instructions for Use (IFU) and Patient Manual (PM). These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components. As of 15 August 2023, the manufacturer has received eight complaints relating to inadequate information regarding useful life content within the IFU or PM. Of the eight complaints, no patient complications were reported. A high-level summary of the updated content and recommendations regarding the care and management of HVAD system components is provided in the customer letter, including the risk associated with the internal battery reaching its end of life is that the controller may not sound the [No Power] alarm when both power sources are disconnected. However, all other controller functions and alarms are not impacted by the internal battery reaching its end of life.
Affected users should refer to the customer letter for further details and follow the action listed on the customer letter issued by the manufacturer.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 Oct 2023