Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with venous blood parameter module, catalog 500V.
This recall has been terminated (originally issued June 28, 2011).
- Recall Initiated
- April 21, 2011
- Posted
- June 28, 2011
- Terminated
- August 6, 2012
- Recall Number
- Z-2682-2011
- Quantity
- 3767 all CDI 500 models
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. The presence of Methylene Blue may interfere with the readings from the shunt sensor for the CDI 500 system in a way that would cause inaccurate pH values. Because the pH value is used to calculate other values, these parameters could also be affected by the presence of Methylene Blue: K
Distribution
Worldwide distribution, including USA, Australia, Barbados, BELGIUM, BRAZIL, CANADA, Chile, Colombia, Costa Rica, Dominican Republic, ECUADOR, El Salvador, France, Germany, Guatemala, Holland, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Korea, Libya, MALAYSIA, MEXICO, PAKISTAN, PANAMA, Paraguay, Saudi Arabia, SINGAPORE, South Africa, Spain, TAIWAN, THAILAND, The Phillipines, TRINIDAD, UNITED ARAB EMIRATES, Uruguay, Venezuela and Vietnam.
Lot / Code Info
lot 1564, 1565, and 1566.
Root Cause
Device Design
Action Taken
Terumo sent URGENT MEDICAL DEVICE CORRECTION letters to Chief of Perfusion, Department of Cardiothoracic Surgery or Director of Operating Room Services, dated 4/21/2011. The letter explained the reason for the correction and the potential hazard. The letter stated that Terumo was updating the Operators Manual for all CDI systems and would provide the manuals to all users when available. Consignees with questions should call 1-800-521-2818. Monday- Friday 8 am- 6 pm.