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
    63847
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-16
  • 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
    Since october 2010 smiths medical has received a total of 4 complaints regarding system errors that cause the medfusion 4000 pump to stop running. there have been no reports of patient injury or death. investigation has identified the root cause to be related to a software anomaly that originated during development that causes a particular history log corruption to occur. further under infrequent circumstances the normal error recovery mechanism for the history corruption (i.E. clear history) is not successful. when the recovery mechanism is not successful the "watchdog fail-safe" alarm is triggered. the combination of the corruption and unsuccessful recovery results in a persistent re-occurrence of the "watchdog fail-safe" on every power-up preventing further use of the pump.

Device

MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP
  • Model / Serial
    Model Catalog: 4000-0100-50 (Lot serial: > 10 CONTACT MANUFACTURER); Model Catalog: 4000-0101-50 (Lot serial: > 10 CONTACT MANUFACTURER); Model Catalog: 4000-0100-249 (Lot serial: > 10 CONTACT MANUFACTURER)
  • Product Description
    Medfusion 4000 Syringe Pump
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

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