Events

Rappel de ADVANCED PERFUSION SYSTEM 1 - BASE UNIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par RYAN MEDICAL DISTRIBUTORS INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    43306
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-08-15
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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

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

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.