Events

Recall of MEDFUSION SYRINGE INFUSION PUMPS

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
    81572
  • Event Risk Class
    II
  • Event Initiated Date
    2009-11-12
  • 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
    Smiths medical has become aware of an increased trend in reports of "motor not running" ("mnr") and "motor rate error" ("mre") alarm message events with certain medfusion syringe infusion pumps models 3010a and 3500 ("pump"). these are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of these pumps. the pump stops delivery when an mnr/mre alarm message event occurs.

Device

MEDFUSION SYRINGE INFUSION PUMPS
  • Model / Serial
    Model Catalog: 3500-500 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 3010A (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 3500-306 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 3500-415 (Lot serial: >100 NUMBERS CONTACT MFR)
  • Product Description
    MEDFUSION SYRINGE INFUSION PUMPS
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

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