Events

Safety Alert for Medfusion Syringe Pump Model Series 3500 and 4000

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Smiths Medical.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-08-02
  • Event Date Posted
    2017-08-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170802.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: smiths medical medfusion syringe pump model series 3500 and 4000 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.

Device

Medfusion Syringe Pump Model Series 3500 and 4000
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Smiths Medical Medfusion Syringe Pump Model Series 3500 and 4000
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical