Medical device manufacturer, Smiths Medical, has issued a medical device alert concerning its Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks, Tubing and LogiCal Kits. [Model number; lot number: Multiple].
The manufacturer noted that specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing, and specific lots of Medex LogiCal Kits, may have been manufactured with insufficient or incomplete welds. As a result, these devices may fail to perform as intended during use.
For pressure monitoring devices (Medex LogiCal Kits) an insufficient or incomplete weld may lead to haemodynamic instability due to incorrect pressure readings, exposure to bodily fluids and infectious agents due to leakage, and particulate embolism from foreign materials entering the device fluid path.
For interventional imaging devices (Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing) this issue may lead to interruption of therapy due to the device becoming dislodged or leaking, and patient injury due to the device components breaking off or becoming dislodged. According to the manufacturer, no reports of deaths or serious injuries has been received.
The manufacturer recommends users to identify and quarantine affected products. If they are distributed to others, this information should be provided to them immediately.
According to the local supplier, the products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 30 March 2021