510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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Z-2186-2011

CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematocrit/Saturation...

Terumo Cardiovascular Systems Corporation / initiated 2010-11-01 / Terminated / root cause: design
FDA source (opens on fda.gov)

Terumo Cardiovascular Systems Corporation began a recall of CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematocrit/Saturation probe, Catalog 500AHCT, Terumo Cardiovascular Systems... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2186-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Terumo Cardiovascular Systems Corporation
Product
CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematocrit/Saturation probe, Catalog 500AHCT, Terumo Cardiovascular Systems Corporations, Ann Arbor, MI. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures.
Product code
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Reason for recall
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 tag
design
FDA 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 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.
Quantity in commerce
3260 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, Trinidad, Taiwan and Uruguay, Germany, Saudia Arabia, Paraguay, South Korea, Dominican Republic, Phillipines, South Africa and UAE.
Product codes and lots
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