Events

Recall of 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
    55911
  • Event Risk Class
    Class 2
  • Event Number
    Z-2480-2010
  • Event Initiated Date
    2010-09-10
  • Event Date Posted
    2010-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92221
  • 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 design document states that the oxygen sensor would operate for 300,000 hours but the supplier of the oxygen sensor indicated that it has a 100,000 hour warranty. the oxygen sensor is a consumable part that slowly depletes over time. at the end of its service life, a depleted oxygen sensor results in a gas system calibration failure or a message to the user prompting service for the gas syst.
  • Action
    Terumo issued a URGENT MEDICAL DEVICE CORRECTION letter dated September 10, 2010, identifying the affected product, the issue prompting the correction, and what actions are to be taken by the customer. The firm included the addendum to the operators manual with the recall letter. The addendum recommended replacement of the oxygen sensor every six months instead of every 12 months. The addendum provided additional user instructions in the event of a calibration failure of the sensor. Customers are to complete and return the enclosed Customer Response Form to the firm. Terumo CVS Customer Service can be contacted by 1-800-521-2818 Monday through Friday, 8 AM  6 PM EST.

Device

Terumo Advanced Perfusion System 1
  • Model / Serial
    Serial numbers 0001-1340.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, including the states of AL,AZ, CA, CO, CT, DC, FL, GA, HI, IA, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, and WV, and the countries of Canada, Indonesia, China, Chile, UAE, Japan, Singapore, UK, Malaysia, Taiwan, Belgium, Korea, Phiippines and Thailand.
  • Product Description
    Terumo Advanced Perfusion System 1, Catalog number 801763, 100/120V System 1 base, Terumo Cardiovascular System, Ann Arbor MI.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

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