Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-06-24Open, ClassifiedEmployee error

  CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit

  Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.

• 2025-03-31Open, ClassifiedSoftware design

  Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

  During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.

• 2016-03-25TerminatedNonconforming Material/Component

  CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37 C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

  Specific CDI Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature value that results in accurate display values on the monitor, does not meet specification. This may cause inaccurate temperature measurement and inaccurate analyte display values on the CDI System 500 monitor. Terumo Cardiovascular Systems (Terumo CVS) received complaints of inaccurate temperature measurements for specific devices distributed since November 5, 2015. These include both new production devices and recently serviced devices. POTENTIAL HAZARD There have been no reported illnesses or injuries as a result of this issue. A user who is not aware that the CDI System 500 is displaying inaccurate temperature values may not manage patient temperature appropriately. Using inaccurate information to manage warming and cooling strategies for a procedure could result in prolonged time on bypass. It could also lead to unnecessarily aggressive temperature management, resulting in excessive hyper or hypothermia, with potential neurologic and organ dysfunction, or increased blood component damage. Inaccurate temperature measurement could also cause inaccurate measurements of other BPM values including potassium (K+), pO2, pCO2, and pH. The greater the temperature inaccuracy, the greater the degree of inaccuracy of these other BPM values due to the dependence of their algorithms on temperature for the calculations. Inaccurate measurement of these values could result in inappropriate patient management strategies being employed to address them with the potential to result in moderate patient injury.

• 2015-09-09TerminatedSoftware design

  CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.

  Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.

• 2014-05-19TerminatedRelease of Material/Component prior to receiving test results

  CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)

  There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the Hemoglobin and Hematocrit measurements are not accurate, there is a potential risk of unnecesary blood transfusion with resulting risk of infection or inflammatory reaction. BPM shipped without meeting manufacturing accep

• 2013-07-13TerminatedSoftware design

  CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

  Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the

• 2013-07-13TerminatedSoftware design

  CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

  Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the

• 2013-07-13TerminatedSoftware design

  CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

  Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.

• 2013-07-13TerminatedSoftware design

  CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

  Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the

• 2013-07-13TerminatedSoftware design

  CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

  Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the