Events

Recall of ARTIS DIALYSIS SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH CANADA 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
    39421
  • Event Risk Class
    III
  • Event Initiated Date
    2015-01-26
  • 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
    Gambro is reminding users of the importance of following the instructions in the operating manual when alarm 642 "arterial chamber level adjustment required" occurs which indicates low blood level in the arterial chamber. gambro has become aware of events where the instructions have not been followed and this may deactivate the alarm mechanism. the manual provides instructions on how to increase the blood level and advises that if the reset buton is pressed without adjusting the blood level the alarm will no longer be triggered during the remaining treatment time. performing the treatment with blood level too low in the arterial chamber may result in microbubbles smaller than 20 micro litres reaching the patient.

Device

ARTIS DIALYSIS SYSTEM
  • Model / Serial
    Model Catalog: 112949 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    Artis Dialysis System equipped with SW 8.09.12 & 8.09.13
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC