UK MHRA has issued a Medical Devices Alert relating to the Pump/gravity blood administration set used in conjunction with Baxter Healthcare’s Flogard and Colleague infusion pumps. The alert can be found here.
The affected product is identified as product reference: VMC9609, lot number: 11K21V628.
Due to a manufacturing error the blue slide clamp may have been incorrectly assembled. As a consequence, if a faulty set is successfully inserted into a pump, blood may be drawn from, instead of infused into, the patient.
There is no risk to patients if the set is used for gravity infusion.
Users are asked to identify and quarantine affected devices and contact the manufacturer to arrange for return/exchange.
Source: MHRA
published: July 5, 2012 in: Alerts/Adverse Events, Baxter, Healthcare