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, Edwards Lifesciences LLC, has issued a medical device safety alert concerning its TruWave Disposable Pressure Transducer, FloTrac Sensors and Acumen IQ Sensors [HKMD No.: 220342, 200427].
The manufacturer recently received customer complaints noting flushing difficulties during setup of the devices listed above. The investigation revealed a manufacturing issue causing a potential occlusion within certain devices. Some devices were fully occluded and could not be flushed, while other devices were partially occluded causing slower flushing. The manufacturer's data indicates the issue potentially occurs in 3% of affected lots.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Oct 2023