Recall Z-2185-2011 · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Terumo Cardiovascular Systems Corporation

CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog 500AVHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.

Date	May 12, 2011 (initiated Nov 1, 2010)
Status	Terminated
Reason	The firm has received 234 complaints of inaccuracy of displayed values on the CDI 101 and 500 monitors. In some cases the customer reported inaccurate potassium values. Other inaccuracies include CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccuracies. The CDI 101 and CDI 500 system are stand alone systems that are used during extracorporeal procedures to continuou
Root cause	Device Design
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 let
Quantity	3260 units all models.
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, Trini
FDA record	Open on fda.gov

510(k) clearances named in this recall

K972962

3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
3M Company, Nov 6, 1997