MHRA issues medical devices alert after patient receives serious injury
A standing aid that could impale patients if not properly assembled and a blood administration set that could extract rather than infuse blood are the subject of warnings from medical regulators.
The Medical and Healthcare products Regulatory Agency (MHRA) has issued two alerts concerning the Encore, Chorus and Sara Plus standing aids from ArjoHuntleigh, and Baxter Healthcare’s pump/gravity blood administration sets used in conjunction with Flogard and Colleague infusion pumps.
The standing aid is the subject of a manufacturer’s Field Safety Notice after an incident in which a patient sustained severe impalement trauma. The problem relates to a knee pad support bracket, which if left exposed contrary to user instructions can pose a risk.
Amended instructions advise the complete removal of the bracket where the kneepad is not required.
A second alert has been issued following reports that due to a manufacturing error, the blue slide clamp used with the blood administration sets from Baxter Healthcare may have been incorrectly assembled. As a result, if a faulty set is successfully inserted into a pump, blood may be drawn from, instead of being infused into, patients. However, it adds there is no risk to patients if the set is used for gravity infusion.
A Field Safety Notice advises quarantining of the equipment (product reference, VMC9609; lot number, 11K21V628) and hospitals are being urged to contact Baxter Healthcare to arrange replacements.