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
    137887
  • Event Risk Class
    II
  • Event Initiated Date
    2012-09-14
  • 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 multiple reports of false alarms generated by the air bubble detection system used with the terumo advanced perfusion system 1 the sarns modular perfusion system 8000 and the sarns perfusion system 9000. terumo cvs' investigation determined that prior corrective actions on the sensor (in 2007 and 2010) did not fully eliminate the possibility for malfunction. therefore terumo cvs has concluded that it is necessary to amend the operator's manuals for its heart-lung machines to: - alert all users of the potential for a malfunction of the air bubble detection system - reinforce the mitigation procedures in the event of a malfunction.

Device

ADVANCED PERFUSION SYSTEM 1 - BASE UNIT
  • Model / Serial
    Model Catalog: 801763 (Lot serial: 1361); Model Catalog: 801763 (Lot serial: 0017); Model Catalog: 801763 (Lot serial: 0020); Model Catalog: 801763 (Lot serial: 0021); Model Catalog: 801763 (Lot serial: 1412); Model Catalog: 801763 (Lot serial: 1411); Model Catalog: 801763 (Lot serial: 1374); Model Catalog: 801763 (Lot serial: 1367); Model Catalog: 801763 (Lot serial: 0013); Model Catalog: 801763 (Lot serial: 1360); Model Catalog: 801763 (Lot serial: 1340); Model Catalog: 801763 (Lot serial: 1312); Model Catalog: 801763 (Lot serial: 1177); Model Catalog: 801763 (Lot serial: 0396); Model Catalog: 801763 (Lot serial: 0193); Model Catalog: 801763 (Lot serial: 0170); Model Catalog: 801763 (Lot serial: 0146); Model Catalog: 801763 (Lot serial: 0144); Model Catalog: 801763 (Lot serial: 0142)
  • Product Description
    TERUMO ADVANCED PERFUSION SYSTEM 1: OPERATOR'S MANUAL ULTRASONIC AIR SENSOR
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.