Events

Recall of ALARIS SYSTEM - SYRINGE PUMP MODULE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CAREFUSION 303 INC..

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
    44694
  • Event Risk Class
    III
  • Event Initiated Date
    2016-08-12
  • 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
    Carefusion has identified an issue with the alaris syringe pump module 8110 software versions 9.15 and 10.5. infusion can unexpectedly stop when an infusion is transitioning from one state to another.

Device

ALARIS SYSTEM - SYRINGE PUMP MODULE
  • Model / Serial
    Model Catalog: 8110 (Lot serial: >10 numbers contact mfg.)
  • Product Description
    ALARIS SYSTEM- SYRINGE PUMP MODULE MODEL 8110 SOFTWARE VERSIONS 9.15 AND 10.5
  • Manufacturer
    CAREFUSION 303 INC.

Manufacturer

CAREFUSION 303 INC.