Recall Z-2683-2011 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Systems, CDI 101 Hematocrit/Oxygen saturation monitoring system, catalog 101.
| Date | Jun 28, 2011 (initiated Apr 21, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 622 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902654 | CDI (TM) SYSTEM 100 MONITORING SYSTEM 3M Health Care, Ltd., Nov 5, 1990 |