The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has posted a medical device safety alert concerning Medfusion Syringe Pump Model Series 3500 and 4000, manufactured by Smiths Medical.
The manufacturer became aware that the thread lock material used on a fastening screw can be ineffective. As a result, the Medfusion pump syringe barrel clamp mechanism may loosen and decrease the pump's ability to accurately detect the outside diameter measurement of the syringe barrel, causing an "Invalid Syringe Size" alarm to occur.
A delay in the initiation of an infusion or an interruption of an active infusion has the potential to result in serious injury or death. The effect to the patient would depend on the patient's condition, the therapy involved, and the amount of time the therapy would be delayed or interrupted.
The "Invalid Syringe Size" alarm triggered as a result of this potential issue alerts healthcare practitioners to the problem. Although no serious injuries or deaths have been reported as a result of this issue, the manufacturer recommends against using the affected devices until repair work is completed.
The users are instructed to locate the affected devices, which would be repaired by the manufacturer.
For details, please refer to the MHRA's website:
https://www.gov.uk/drug-device-alerts/field-safety-notice-24-to-28-july-2017
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 August 2017