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 HeartWare, has issued a medical device safety alert concerning its HeartWare Ventricular Assist Device (HVAD) [HKMD No.: 180485].
The manufacturer identified that additional clarity to the Patient Manual (PM) was required around cleaning the Power Source Connectors (Controller AC Adapter, DC Adapter, and Battery). The pins on the interior of the power source connectors are coated with a lubricant that should not be removed as it is intended to help prevent unexpected power switching. Attempting to clean the interior of a power source connector can lead to damage of the HVAD system components which may impact controller and pump performance. Potential performance issues from damaging the power source connectors range from negligible harm to an unanticipated VAD Stop.
The manufacturer will update Instructions for Use and Patient Manual. Affected users should follow the advice listed on the customer letter provided by the manufacturer.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 Jan 2022