Events

Recall of Device Recall Terumo Advanced Perfusion System 1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

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
    65354
  • Event Risk Class
    Class 2
  • Event Number
    Z-1968-2013
  • Event Initiated Date
    2013-07-26
  • Event Date Posted
    2013-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118617
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Reason
    The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. specifically, if the user is adjusting the system 1 centrifugal pump speed via the central control monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.
  • Action
    Terumo CVS, sent an URGENT MEDICAL DEVICE RECALL notification letter dated July 26, 2013, to all affected customers explaining the correction to the operators manual, potential hazards and what to do in response to the issue. If you have any questions or concern please contact Terumo CVS Customer Service 1-800-521-2818 Recall Fax 1-734-741-6149 Customer Service Hours: Monday  Friday, 8 AM - 6 PM ET

Device

Device Recall Terumo Advanced Perfusion System 1
  • Model / Serial
    Catalog number: 801763
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the countries of Australia, Dubai, Hong Kong, Indonesia, Singapore, China, Mexico, British Columbia, Taiwan, Thailand, Chile, Malaysia, Japan, Belgium, United Arab Emirates (UAE), South Korea, Manila and Canada.
  • Product Description
    Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 || The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns " or similar equipment.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA