Events

Recall of MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITHS MEDICAL CANADA LTD. (SIMS).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65102
  • Event Risk Class
    II
  • Event Initiated Date
    2013-11-20
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    In may 2013 smiths medical received a complaint concerning a medfusion 4000 pump with thermal damage to the ac receptacle as a result of an electrical short. an in-depth investigation performed by a third-party laboratory concluded that an electrical short can occur when saline solution or other conductive fluids (ie. potassium chloride) enter the pump's ac power receptacle. when this happends sparking and/or flames accompanied by smoke may appear at the power receptacle. the pump and ac power cord are constructed of flame retardant materials therefore the sparks/flames extinguish within seconds.

Device

MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP
  • Model / Serial
    Model Catalog: 4000-0101-50 (Lot serial: >100 numbers contact mfg); Model Catalog: 4000-0100-50 (Lot serial: >100 numbers contact mfg); Model Catalog: 4000-0101-51 (Lot serial: >100 numbers contact mfg)
  • Product Description
    Medfusion 4000
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    HC