Events

Recall of ALARIS SYSTEM - PUMP

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
    74857
  • Event Risk Class
    II
  • Event Initiated Date
    2012-08-08
  • 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
    The alaris pump module model 8100 manufactured between august 2010 and july 2011 may experience an intermittent motor stall during infusion. the investigation revealed that a mechanical binding within the mechanism assembly is resulting in a motor stall. when a motor stall occurs the alaris pc unit and the alaris pump module display the visual error code 242.4030 with an audible alarm and is followed by a termination of infusion.

Device

ALARIS SYSTEM - PUMP
  • Model / Serial
    Model Catalog: 8100LVP (Lot serial: Contact manufacturer.); Model Catalog: 8100LVP (Lot serial: >10 serial numbers.)
  • Product Description
    Alaris Pump Module Model 8100
  • Manufacturer
    CAREFUSION 303 INC.

Manufacturer

CAREFUSION 303 INC.