Events

Recall of Device Recall CDI 500 Blood Parameter Monitoring System

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
    57194
  • Event Risk Class
    Class 2
  • Event Number
    Z-2189-2011
  • Event Initiated Date
    2010-11-01
  • Event Date Posted
    2011-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95641
  • 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
    Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
  • Reason
    The cdi 500 monitor may display inaccurate values. these errors include inaccurate potassium, co2, hematocrit, o2 saturation, ph, hemoglobin and other miscellaneous inaccuracate values.
  • Action
    The firm, TERUMO, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 27, 2010 to its customers. The letter described the product, problem and actionst to be taken. The customers were instructed to reveiw this notice; assure that customers are ware of this notice; confirm receipt of this notification by faxing the attached Customer Response Form, and place the attached stickers in a visible place in the Operators' Manuals, such as the inside of the front cover, if additional stickers are needed, the customers should contact Terumo CVS Customer Service at 1-800-521-2818. The letter states that when a displayed value is significantly different from expectations based on the clinical situatioin, the user should verify the accuracy by independent means before treating. The letter included "Caution" stickers that were to be applied to the CDI system operatros manual. The letter also states "Please note that we are not recommending that you stop using your CDI monitor system." If you have any questions or concerns, please contact Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours are from Monday-Friday, 8AM - 6PM EST.

Device

Device Recall CDI 500 Blood Parameter Monitoring System
  • Model / Serial
    1564, 1565 and 1566.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of : Australia, Barbados, Belgium, Brazil, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatamala, Hong Kong, Honduras, Jordan, Japan, Libya, Mexico, Malaysia, Panama, PH, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad, Taiwan and Uruguay, Germany, Saudia Arabia, Paraguay, South Korea, Dominican Republic, Phillipines, South Africa and UAE.
  • Product Description
    CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog number 500V , Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. || The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. The CDI 500 system is a stand alone systems that is used during extracorporeal procedures to continuously monitor the blood in the extracorporeal circuit, providing ongoing information about the blood parameters.
  • 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