# K972962: 3M Cdi Blood Parameter Monitoring System 500

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Nov 6, 1997 after 87 days
- Product code: DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4330
- Recalls of this device: 26 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K854357 (1986). 3 ancestors in all.
10 later devices descend from it; 3 cite it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890113: The Cdi (R) System 400, Cardiovascular Devices, Inc. (1989) Summary page 1.
- K902654: Cdi (TM) System 100 Monitoring System, 3M Health Care, Ltd. (1990) Summary page 1.
- K854357: Gem-6, with Components, Diamond Electro-Tech, Inc. (1986) Summary page 1.

## Most influential descendants
- K110957: M4 Monitor (2011), 4 descendants of its own
- K173591: Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (2018), 3 descendants of its own
- K090147: Blood Monitoring Unit, Model Bmu 40 (2009), 3 descendants of its own
- K181942: Quantum Ventilation Module (2018), 2 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own

## Recalls of this device
- May 9, 2014 · Class II · Z-1634-2014: 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 Hematocr
- Feb 27, 2013 · Class II · Z-1731-2013: 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 t
- Feb 27, 2013 · Class II · Z-1732-2013: 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 Hemato
- Feb 27, 2013 · Class II · Z-1730-2013: 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 t
- Feb 27, 2013 · Class II · Z-1734-2013: 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 t
- Feb 27, 2013 · Class II · Z-1733-2013: 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 t
- Feb 3, 2012 · Not classified · Z-1379-2012: Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their
- Feb 3, 2012 · Not classified · Z-1380-2012: Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their
- Feb 3, 2012 · Not classified · Z-1381-2012: Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their
- Feb 3, 2012 · Not classified · Z-1378-2012: Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their
- Feb 3, 2012 · Not classified · Z-1382-2012: Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their
- Dec 6, 2011 · Not classified · Z-0672-2012: In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing 
- Dec 6, 2011 · Not classified · Z-0673-2012: In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing 
- Dec 6, 2011 · Not classified · Z-0674-2012: In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing 
- Dec 6, 2011 · Not classified · Z-0675-2012: In a recent review of in-house Service Procedures for the CDI Blood Parameter Monitoring System 500, Terumo Cardiovascular Systems (Terumo CVS) found that one of the procedures it had been performing 
- Sep 23, 2011 · Not classified · Z-0142-2012: Terumo CVS identified a defective circuit board, which could potentially cause the CDI monitor to not function after a power loss. Once power is lost, the monitor will not power up again, even if AC o
- Apr 21, 2011 · Not classified · Z-2679-2011: 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 
- Apr 21, 2011 · Not classified · Z-2678-2011: 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 
- Apr 21, 2011 · Not classified · Z-2682-2011: 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 
- Apr 21, 2011 · Not classified · Z-2681-2011: 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 
- Apr 21, 2011 · Not classified · Z-2680-2011: 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 
- Nov 1, 2010 · Not classified · Z-2188-2011: The CDI 500 monitors may display inaccurate values. These errors include inaccurate potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccurate values.
- Nov 1, 2010 · Not classified · Z-2189-2011: The CDI 500 monitor may display inaccurate values. These errors include inaccurate potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccuracate values.
- Nov 1, 2010 · Not classified · Z-2185-2011: The firm has received 234 complaints of inaccuracy of displayed values on the CDI 101 and 500 monitors. In some cases the customer reported inaccurate potassium values. Other inaccuracies include CO2,
- Nov 1, 2010 · Not classified · Z-2186-2011: The firm has received 234 complaints of inaccuracy of displayed values on the CDI 101 and 500 monitors. In some cases the customer reported inaccurate potassium values. Other inaccuracies include CO2,
- Nov 1, 2010 · Not classified · Z-2187-2011: The CDI 500 monitor may display inaccurate values. These errors include inaccurate potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccuracate values.

## Indications for use
The 3M CDI 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 500’s integral printer provides a hard copy of displayed parameters.

Source page: https://510kreport.com/device/K972962
Methodology: https://510kreport.com/methodology