Events

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
    74072
  • Event Risk Class
    II
  • Event Initiated Date
    2013-08-19
  • 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
    Terumo cardiovascular systems (terumo cvs) has received three reports of a terumo advanced perfusion system 1 displaying a pressure reading of '999.' terumo cvs has confirmed that in one of these cases the user was unable to clear the pressure alarm and restart the pump. note: the system displays '999' at pressures greater than +900mmhg. the reading can indicate a true high pressure or a malfunction of the pressure transducer or cable. the operator's manual for the terumo system 1 does not provide instruction on how to clear the '999' pressure reading.

Device

ADVANCED PERFUSION SYSTEM 1 - BASE UNIT
  • Model / Serial
    Model Catalog: 801763 (Lot serial: > 10 contact manufacturer)
  • Product Description
    Terumo Advanced Perfusion System 1
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.