The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Easypump C-bloc RA OnDemand, manufactured by B. Braun Medical Limited. The affected article number is 4440008 and the affected batch numbers are 152803,182313 and 192472.
The manufacturer recently determined that in a small quantity of Easypump C-bloc RA pump with OnDemand bolus button, the button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. In this condition, the patient may receive continuous infusion at a rate greater than expected.
The manufacturer's complaint analysis determined that approximately 0.04% of the pumps (i.e.: approximately 4 out of 10,000) may develop this condition. If this condition occurs, it may not be detected during filling or priming of the pump. The use of a pump with this condition may result in over medication of the patient and may potentially result in serious patient injury.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON273701
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 21 May 2013