Recall of ADVANCED PERFUSION SYSTEM 1 - BASE UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RYAN MEDICAL DISTRIBUTORS 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
    43306
  • Event Risk Class
    III
  • Event Initiated Date
    2013-08-15
  • Event Country
  • 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
    Terumo cardiovascular systems (terumo cvs) has become aware that under certain circumstances a terumo advanced perfusion system 1 centrifugal pump "service pump" message may display due to user induced motor movement. in this instance the terumo system 1 will recognize the movement (as it is designed to do} and display a "service pump" message. the user might interpret this message as a pump that requires service rather than a message displayed due to pump movement while not activated. because of these instructions the user may unnecessarily remove and replace a properly functioning piece of equipment (if the message was due to a user-induced action).

Device

  • Model / Serial
    Model Catalog: 801763 (Lot serial: > 10 contact manufacturer)
  • Product Description
    Terumo Advanced Perfusion System 1
  • Manufacturer

Manufacturer