Events

Recall of ALARIS PATIENT CARE SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH CANADA.

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
    62679
  • Event Risk Class
    I
  • Event Initiated Date
    2009-07-13
  • 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
    1)occluded tubing may cause medication not to be delivered. 2)misprogrammed infusion caused by ignoring the warning message. 3) specific esd protection circuitry may result in an over or under infusion. 4)certain fluids solidify in the pumping mechanism. 5) iui connector failure when they become corroded or contaminated.

Device

ALARIS PATIENT CARE SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER
  • Model / Serial
    Model Catalog: 8015 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8110 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8650 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8600 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8120 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8300 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8220 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8000APM (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8100LVP (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8210 (Lot serial: MORE THAN 10 SERIAL NUMBERS)
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    ALARIS PATIENT CARE SYSTEM-SERVER MODUL
  • Manufacturer
    CARDINAL HEALTH CANADA

Manufacturer

CARDINAL HEALTH CANADA
  • Manufacturer Address
    VAUGHAN
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC