Recall Z-1944-2011 ยท DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
| Date | Apr 11, 2011 (initiated Nov 1, 2010) |
| Status | Terminated |
| Reason | Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate. |
| Root cause | Device Design |
| Action | On 11/1/2010, Terumo sent "URGENT MEDICAL DEVICE CORRECTION" notices to Chief Perfusionist, Department of Cardiovascular Surgery or Director of Operating Room Services. The letter informed the consignees about the incidents of the CDI 100 and 101 displaying inaccurate values. The letter states that when a displayed value is significantly different from expectations based on the clinical situation, 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 operators manual. |
| Quantity | 1032 units |
| Distribution | US, India, Colombia, Taiwan, Venezuela, Vietnam, Puerto Rico, Malaysia, Sri Lanka, Brazil, Indonesia, Pakistan, Chile, Germany, Hong Kong, Japan, AE, Singapore, Austria, Belgium and Thailand. |
| 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 |