Important Safety Alerts

The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning all models of Select 3D and Select CAP Arterial Cannula product families manufactured by Medtronic due to reports of the cannula body splitting near the suture collar.. The affected model numbers are 78618, 78620, 78622, 78624, 78718, 78720, 78722, CB78722, 78724, 78818, 78820, 78822, 78920, 78922, 78924, 3Y90R3 and C300901B.

Since January 2012, the manufacturer has received nine such reported events which represent a 0.06% occurrence rate. Of these, one was associated with a patient death and one other was associated with serious injury.

According to the manufacturer, potential patient harms resulting from this type of splitting may include:

• The delivery of inadequate blood flow, possibly resulting in ischemia or inadequate perfusion.
• Difficulty in inserting/removing the cannula tip, possibly resulting in a procedural delay, vessel damage, dissection or other complications that may contribute to patient death.

The manufacturer advises users to identify and quarantine all affected products and return them to the manufacturer.

For details, please refer to the following link:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON371783

According to the local supplier, the affected products were not distributed in Hong Kong.

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 11 February 2014