The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Logical Hemodraw Closed Blood Sampling Systems, manufactured by Smiths Medical.
The manufacturer has become aware of a potential risk of inadvertent introduction of air into the affected device via a porous plug, if the device is used incorrectly. If a user incorrectly orients the zero stopcock when activating the Hemodraw reservoir, air can enter the fluid pathway. Air in the line, if not properly handled by the clinician, can be introduced into the patient under specific situations, which are highly unlikely according to manufacturer. Smiths Medical has received no reports of patient injury or death related to this issue.
As a precautionary measure, Smiths Medical is changing its Instruction for Use to instruct users to fit a non-vented cap to the stopcock after priming. The field safety notice provides these additional instructions to users who have been supplied the affected products. The manufacturer will also supply users with non-vented caps for the affected devices.
For details, please refer to the following MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON213146
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 11 December 2012