—#95641

Product

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.

FDA product code: DRY — Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K972962
Affected lot / code info: 1564, 1565 and 1566.

Why it was recalled

The CDI 500 monitor may display inaccurate values. These errors include inaccurate potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccuracate values.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-11-01
Posted by FDA: 2011-05-12
Terminated: 2014-07-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95641. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.