Sensor, Blood-gas, In-line, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4410
Recent MDR events
341 adverse event reports on file
- TERUMO CDI 100 MONITORMar 5, 2015MalfunctionTerumo Cardiovascular Systems Corp.1828100-2015-00147
- TERUMO CDI 100 MONITORFeb 10, 2015MalfunctionTerumo Cardiovascular Systems Corp.1828100-2015-00133
- TERUMO CDI 100 MONITORFeb 10, 2015MalfunctionTerumo Cardiovascular Systems Corp.1828100-2015-00132
- TERUMO CDI 100 MONITOROct 23, 2014MalfunctionTerumo Cardiovascular Systems Corp.1828100-2014-00942
- TERUMO CDI 101 MONITOROct 20, 2014MalfunctionTerumo Cardiovascular Systems Corp.1828100-2014-00870
- TERUMO CDI 101 MONITOROct 16, 2014MalfunctionTerumo Cardiovascular Systems Corp.1828100-2014-00878
- TERUMO CDI 100 MONITORJun 25, 2014MalfunctionTerumo Cardiovascular Systems Corp.1828100-2014-00542
- TERUMO CDI 100 MONITORMay 2, 2014MalfunctionTerumo Cardiovascular Systems Corp.1828100-2014-00381
- TERUMO CDI 100 BLOOD MONITORApr 28, 2014MalfunctionTerumo Cardiovascular Systems Corp.1828100-2014-00357
- TERUMO CDI 100 MONITORJan 27, 2014MalfunctionTerumo Cardiovascular System Corp1828100-2014-00053
Event type breakdown
Recalls
2 recall events for this product code
- Terumo Cardiovascular Systems CorporationTerminatedApr 11, 2011
Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.
Z-1943-2011 · View FDA record ↗ - Terumo Cardiovascular Systems CorporationTerminatedApr 11, 2011
Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass.
Inaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be inaccurate.
Z-1944-2011 · View FDA record ↗
Registered firms
5 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Medtronic, Inc.Feb 17, 2010
K093650 · BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
- International Biophysics Corp.Mar 20, 1997
K963698 · CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4
- Medtronic Bio-Medicus, Inc.Jan 16, 1996
K954501 · BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
- 3M Health Care, Ltd.Nov 5, 1990
K902654 · CDI (TM) SYSTEM 100 MONITORING SYSTEM
- Cardio Metrics, Inc.Aug 14, 1990
K900860 · PERFUSION MONITOR
- Cardiovascular Devices, Inc.Feb 19, 1987
K864703 · MODIFIED GAS-STAT(TM) MONITORING SYSTEM
- Cardiovascular Devices, Inc.Apr 17, 1984
K840749 · GAST STAT MONITORING SYSTEM
- Cardiovascular Devices, Inc.Dec 22, 1982
K822000 · EXTRACORPOREAL BLOOD GAS SYSTEM