Patent Description:
The present disclosure relates generally to monitoring fluid flow through a fluid circuit and, in particular to systems and methods for monitoring and ex-vivo operating fluid flow through a medical fluid circuit using hydrostatic pressure.

A variety of available blood processing systems allows for the collection and processing of particular blood components, rather than whole blood, from donors or patients. In the case of a blood donor, whole blood is drawn from the donor, a desired blood constituent isolated and collected, and the remaining blood components returned to the donor. By removing only particular constituents rather than whole blood, it takes the donor's body a shorter time period to recover to normal blood levels, thereby increasing the frequency with which the donor may donate blood. It is beneficial to increase in this manner the overall supply of blood constituents made available for health care, such as red blood cells (RBCs), leukocytes, plasma, and/or platelets, etc..

The separation phase of blood components from whole blood may be achieved through a spinning membrane or centrifugation, in which whole blood is passed through a centrifuge or membrane after it is withdrawn from the patient. To avoid contamination and possible infection of the patient, the blood is preferably contained within a sealed, sterile fluid flow system during the entire separation process. Typical blood processing systems thus may include a permanent, reusable hardware assembly containing the hardware (drive system, pumps, valve actuators, programmable controller, and the like) that pumps the blood, and a disposable, sealed and sterile fluid circuit that is mounted in cooperation on the hardware. In the case of separation via centrifugation, the hardware assembly includes a centrifuge that may engage and spin a separation chamber of the disposable fluid circuit during a blood separation step. The blood, however, may make actual contact only with the fluid circuit, which assembly may be used only once and then discarded. In the case of separation via a spinning membrane, a disposable single-use spinning membrane may be used in cooperation with the hardware assembly and disposable fluid circuit.

In the case of separation via centrifugation, as the whole blood is spun by the centrifuge, the heavier (greater specific gravity) components, such as red blood cells, move radially outwardly away from the center of rotation toward the outer or "high-G" wall of the separation chamber of the fluid circuit. The lighter (lower specific gravity) components, such as plasma, migrate toward the inner or "low-G" wall of the separation chamber. Various ones of these components can be selectively removed from the whole blood by forming appropriately located channeling seals and outlet ports in the separation chamber of the fluid circuit.

In the case of separation via a spinning membrane, whole blood may be spun within a disposable spinning membrane, rather than within a separation chamber of a fluid circuit. Larger molecules, such as red blood cells, may be retained within one side of the membrane, while the smaller molecules, such as plasma, may escape through the pores of the membrane to the other side of the membrane. Various ones of these components can be selectively removed from the whole blood by forming appropriately located outlet ports in the housing of the membrane column. Various types of columns with different pore sizes may be used, depending on the components to be separated.

It is common for two or more medical solution containers to be used simultaneously during blood processing procedures. For example, various combinations of saline solution bags, anti-coagulant bags, RBC additive solution bags, platelet additive solution bags, and/or a variety of replacement fluids, such as albumin, RBCs, plasma, etc. may be used in a blood processing procedure. Although these solutions have very different functions and properties, the containers in which they are held may be similar in appearance, and it may often be up to a human operator to make sure that a solution container is connected to the correct fluid pathway.

According to a first embodiment, the present disclosure is directed to a bodily fluid processing system for monitoring fluid flow in a medical fluid procedure using hydrostatic pressure, comprising: a hardware component (<NUM>) controlled by a programmable controller, a fluid circuit (<NUM>) comprising a plurality of fluid pathways configured to mount and associate with the hardware component (<NUM>), wherein the hardware component (<NUM>) comprises a pressure sensor (PS, PS1, PS2, PS3, PS4) in communication with the programmable controller and a fluid pathway; the fluid circuit (<NUM>) includes a container (<NUM>, <NUM>, <NUM>, <NUM> a, <NUM>) configured for fluid communication with the pressure sensor (PS, PS1, PS2, PS3, PS4) and configured to receive a volume of a fluid; and the controller is configured to: initiate a phase of the medical fluid procedure associated by the controller with a plurality of ranges of pressure values authorized at specific times for the pressure sensor (PS, PS1, PS2, PS3, PS4); receive a first pressure value from the pressure sensor (PS, PS1, PS2, PS3, PS4) measured at a first time, when the container (<NUM>, <NUM>, <NUM>, <NUM> a, <NUM>) is not in fluid communication with the pressure sensor (PS, PS1, PS2, PS3, PS4); receive a second pressure value from the pressure sensor (PS, PS1, PS2, PS3, PS4) measured at a second time, when the container (<NUM>, <NUM>, <NUM>, <NUM> a, <NUM>) is in fluid communication with the pressure sensor, with the second pressure value being indicative of hydrostatic pressure applied by the fluid within the container (<NUM>, <NUM>, <NUM>, <NUM> a, <NUM>) and the fluid pathway; compare a difference between the second pressure value and the first pressure value to an authorized range of pressure values; and execute a response action if the difference is not within the authorized range of pressure values.

According to another embodiment, the present disclosure is directed to a computer-implemented method for ex vivo operating and monitoring fluid flow through a bodily fluid processing system using hydrostatic pressure, comprising: providing a fluid circuit (<NUM>) comprising a plurality of fluid pathways configured to mount and associate with a hardware component (<NUM>) controlled by a programmable controller, wherein the hardware component (<NUM>) comprises a pressure sensor (PS, PS1, PS2, PS3, PS4) in communication with the programmable controller and a fluid pathway; providing a container (<NUM>, <NUM>,<NUM>, <NUM> a, <NUM>) part of the fluid circuit (<NUM>) configured for fluid communication with the pressure sensor (PS, PS1, PS2, PS3, PS4) and configured to receive a volume of a fluid;measuring a change in pressure values between a first and second time at the pressure sensor (PS, PS1, PS2, PS3, PS4) from when the volume of fluid is not in communication with the pressure sensor (PS, PS1, PS2, PS3, PS4) to when the volume of fluid is in communication with the pressure sensor (PS, PS1, PS2, PS3, PS4); with the pressure value measured at the second time being indicative of hydrostatic pressure applied by the fluid within the container (<NUM>, <NUM>, <NUM>, <NUM> a, <NUM>) and the fluid pathway, determining the volume of the fluid within the container (<NUM>, <NUM>, <NUM>, <NUM> a, <NUM>) or a presence or absence of a fluid connection to the fluid pathway based on the change in pressure values; and executing a response action if the volume of the fluid within the container (<NUM>, <NUM>, <NUM>, <NUM> a, <NUM>) is not within an authorized range of volumes for the time period, or if the presence or absence of a fluid connection is not authorized.

Features, aspects, and advantages of the present embodiments will become apparent from the following description, appended claims, and the accompanying exemplary embodiments shown in the drawings, which are briefly described below.

There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described and claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein.

Some embodiments may verify that a solution containing a correct fluid volume is connected to the correct fluid pathway during a fluid processing procedure.

Some embodiments may enable verification of a solution container's correct connection to the intended fluid pathway prior to drawing fluid into the fluid pathway and thereby minimize waste of disposable circuits in biological fluid processing.

Some embodiments may improve monitoring of the timing of solution container installation on a fluid processing hardware to ensure that a solution container is installed at the correct stage of the fluid procedure.

There have been continuing efforts to automate the apparatus and systems used in the collection and/or processing of blood and blood components, and an automated blood component separator for such collection/processing may be employed. One class of such automated separators employs relatively rotating surfaces, at least one of which carries a porous membrane. An example of such a membrane separator is disclosed in <CIT>, although any suitable membrane separator may be used. Another class employs a centrifuge that utilizes centrifugal separation principles. An exemplary centrifugal separator is disclosed in <CIT> and <CIT>, although any suitable centrifugal separator may be used.

Both membrane separation and centrifugal separation systems may involve a durable processing system or device used in combination with a disposable processing set or circuit. The durable processing system may include a pump assembly that interacts with one or more of the components of the disposable circuit to draw blood or other bodily fluid from a blood source and move the blood or bodily fluid to another location within the disposable circuit by moving fluid through a fluid flow path.

<FIG> and <FIG> show an exemplary separation device useful in the separation and processing of blood components, e.g., red blood cells, white blood cells, platelets, plasma, etc. The separator <NUM> may include a hardware component <NUM> and a disposable processing kit <NUM> mounted thereon. In one embodiment, the separation principle used by the separator may be based on centrifugation, but an automated separator based on a different separation principle (e.g., spinning membrane) may also be used.

With respect to the device shown in <FIG> and <FIG>, a rotating centrifuge may be housed within hardware component <NUM>. The hardware component <NUM> may also comprise a plurality of hangers <NUM> for hanging fluid containers <NUM>. One or more hangers <NUM> may also function as a weight scale that is in communication with a pre-programmed controller of the hardware component <NUM>. Disposable kit <NUM> may include plastic containers <NUM> for holding fluid, and tubing <NUM> defining flow paths for movement of the blood, blood components and other medical fluids through the fluid circuit of kit <NUM>. The plastic containers <NUM> and the tubing <NUM> may be configured with corresponding access devices (not illustrated), e.g., spike connector, luer connector, cannula, break-away cannula, etc., to minimize incorrect connections. For example, a saline solution bag may be configured to be accessed by a spike connector, while an anticoagulant bag is configured to be accessed by luer connector.

The disposable processing kit <NUM> may also include one or more cassettes <NUM> (i.e., cassettes 56a, 56b and 56c shown in <FIG>) which may interface with the front panel of hardware component <NUM>. Cassettes 56a, 56b and 56c may include flow paths, pressure sensors, and valve stations. A series of pneumatically or electrically operated valves (numbered <NUM>-<NUM> in <FIG>, for example) under the control of the pre-programmed controller of hardware component <NUM> may selectively allow and restrict flow through the flow paths of the cassette and ultimately through the tubing of disposable kit <NUM>. Pressure sensors (numbered PS1-<NUM> in <FIG>, for example) disposed on the front panel of hardware component <NUM> may also be in communication with the controller to monitor the fluid procedure. Disposable kit <NUM> may further include a processing chamber shown generally at <NUM> of <FIG> (which may be mounted on a rotor/spool of the centrifuge). Processing chamber <NUM> may have a sub-chamber <NUM> wherein blood or blood components are separated under the influence of centrifugal force (i.e., the "separation chamber') and a sub-chamber <NUM> where blood components from sub-chamber <NUM> may be further processed, separated and/or collected (i.e., the "concentration chamber"). In a spinning membrane separation system, the separation chamber and concentration may comprise a spinning membrane separator. Details of an automated separator suitable for use with the systems and methods described herein are set forth in the aforementioned <CIT> and <CIT> and <CIT>.

During a particular processing procedure, the pre-programmed controller may operate the separator and processing chamber associated therewith to separate blood into its various components as well as operate one or more pumps and clamps to move blood, blood components, saline, anticoagulant, and/or additive solution through the various openable valves and tubing segments of a processing set <NUM>, such as the one illustrated in <FIG>. This may include, for example, initiating and causing the separation of red blood cells (RBCs), white blood cells (WBCs), mononuclear cells (MNCs), platelets, and/or plasma from whole blood in a separation chamber and pumping additive solution/saline/anticoagulant from a source through selected valves and tubing segments to prime or purge the tubing segments and/or to displace fluid (such as plasma) that may reside or remain in the tubing. The various processing steps performed by the pre-programmed automated blood processing device may occur separately, in series, simultaneously or any combination of these.

According to an exemplary embodiment, in a first phase of a fluid processing procedure, it may be desirable to prime the disposable kit <NUM> to purge air from the various fluid pathways of the kit <NUM>. In one embodiment, saline may be used to prime the fluid circuit <NUM>. <FIG> depicts a saline container <NUM> associated with hanger WS4 and connected to cassette 56a and pressure sensor PS3 via a fluid path comprising tubing <NUM>, y-connector <NUM>, and valves <NUM> and <NUM> of cassette 56a. The hanger WS4 may also be a weight scale configured to measure the weight of container <NUM> and provide input to the controller. The priming phase of one embodiment of a fluid processing procedure may be associated with, e.g., a <NUM> volume of saline for priming fluid. The controller may be configured to check that the initial weight reading at hanger WS4 at the beginning of the priming phase is within a programmed range, e.g., approximately <NUM> to <NUM> grams for a <NUM> saline solution. The controller may also be configured to monitor and detect a gradual decrease in weight readings at hanger WS4 and no changes in weight readings at other hangers WS1-<NUM> and WS5 during the priming phase as a confirmation measure that priming fluid is actually exiting the container <NUM> on hanger WS4 as intended.

Throughout the priming phase, the controller may also be configured to receive input from pressure sensor PS3 to which container <NUM> may be in fluid communication when the priming phase has initiated. Receiving and checking input from the pressure sensor PS3 may provide a confirmation measure indicating that not only is the saline container <NUM> hanging on saline hanger WS4, but the saline container <NUM> is also properly connected to tubing <NUM> to be in fluid communication with the pressure sensor PS3. A confirmation measure for proper connection to tubing <NUM> may be advantageous when, for example, the tubing <NUM> requires manual connection (e.g., via a cannula, luer connection, spike connection, etc.) at any point before or during the fluid procedure or otherwise is not irreversibly connected to the saline container <NUM> and therefore carries a risk of incorrect connection. Receiving and checking input from the pressure sensor PS3 may also provide earlier feedback when an incorrect connection leads to fluid exiting the wrong container than relying on hanger weight readings alone, which may provide feedback when incorrect fluid has already been substantially drawn into the kit <NUM>, requiring the kit <NUM> to be discarded.

Referring to <FIG>, a process by which the controller may receive hydrostatic pressure input from a pressure sensor, e.g., sensor PS3, and monitor the correct timing and/or identity of fluid flow will be described. Using the fluid path between saline container <NUM> and pressure sensor PS3 as an example, when the disposable kit <NUM> is first installed onto the hardware component <NUM> but prior to initiation of priming, the saline within container <NUM> may not be in fluid communication with pressure sensor PS3. If container <NUM> and tubing <NUM> are initially disconnected, an access device may establish fluid communication at the appropriate time of the procedure. If container <NUM> and tubing <NUM> are initially connected, a clamp <NUM> or similar device may cut off fluid communication until the fluid is required, e.g., at the priming phase. Referring to <FIG>, during the time when fluid communication is disconnected by clamp 44a between container 41a and pressure sensor PS, the pressure sensor PS may produce baseline pressure readings, e.g., reflective only of atmospheric pressure or a designated baseline pressure. <FIG> is an exemplary pressure versus time graph indicating pressure readings at pressure sensor PS. Point A on the graph in <FIG> is representative of the baseline pressure during which fluid communication has been cut off between the container 41a and the sensor PS. <FIG> shows the baseline pressure being approximately <NUM> Hg, but it should be understood that the baseline pressure may be different for each type of kit and/or may be calibrated independently at the time of each fluid procedure or each phase.

At the start of the priming phase, fluid communication may be established, e.g., by opening clamp 44a, and the fluid within container 41a may immediately exert pressure against the air column 45a, leading to an increased pressure reading at pressure sensor PS. The pressure reading will be largely determined by the hydrostatic pressure of the air column 45a and the much larger hydrostatic pressure contributed by the liquid column having height H (<FIG>) within container 41a. The equation for hydrostatic pressure is P = ρgh, where ρ is the density of the fluid, g is the gravitational acceleration, and h is the height of the fluid column exerting the hydrostatic pressure P. Point B on the graph in <FIG> is representative of the pressure measured at sensor PS when fluid communication has been initiated between container 41a and the sensor PS in an embodiment in which container 41a is filled with <NUM> of saline. <FIG> shows that the pressure associated with <NUM> of saline at Point B is approximately <NUM> Hg. The pressure associated with <NUM> of saline may further be designated as a range. For example, for Point B of <FIG>, a pressure reading within <NUM>-<NUM> Hg may be associated with <NUM> of saline provided within a particular container. It should be understood that the pressure associated with <NUM> of saline may be different for different container shapes for container 41a. For example, in an embodiment in which the shape of container 41a comprises a larger x,y-dimension, the same <NUM> volume of saline will possess a smaller height, leading to a smaller hydrostatic pressure exerted by the saline, as determined by the equation P = ρgh. Different container shapes of various fluid manufacturers may therefore be taken into account by programming into the controller, e.g., via a database table comprising different fluid volumes and their associated H and P values, based on, e.g., product codes, serial numbers, product names, and/or manufacturer code for identification. The H and P values for variously shaped containers commonly used for the fluid procedure may be empirically derived and programmed into the controller. When a particular container is to be used for the fluid procedure, the container information may be inputted or scanned into the system at the beginning of the procedure.

Point C on the graph in <FIG> is representative of the pressure measured at sensor PS when fluid communication has been initiated between container 41a and the sensor PS in an alternate embodiment in which container 41a is filled with <NUM> of saline. <FIG> shows that the pressure associated with <NUM> of saline at Point C is approximately <NUM> Hg, but it should be understood that the pressure associated with <NUM> of saline may be different for different container shapes for container 41a, as explained previously. For both <NUM> and <NUM> fluid volumes and any other fluid volume, it may be desirable for the controller to verify fluid connection based on pressure readings taken by the pressure sensor PS as soon as fluid communication is established between container 41a and the sensor PS prior to substantial fluid being drawn into the tubing 42a and the kit <NUM> from container 41a. Utilizing pressure readings as soon as possible may not only allow for minimal contamination of the kit <NUM> in the event of an incorrect connection or incorrect fluid flow timing and therefore maximize kit salvageability, but the variability in measurement of the pressure readings at points B and C (as determined by the equation P = ρgh) may also be minimized by measuring pressure when the height H of the liquid column is at its lowest, i.e. before any liquid enters a length of tubing 42a that would contribute to height h.

The controller may then be configured to compare the measured pressure readings against authorized pressure ranges programmed for the fluid procedure and execute a response action if the measures pressure readings are not within the authorized ranges at specific times. The controller may also be configured to measure pressure at other pressure sensors, e.g., PS1-<NUM> and PS4 of cassette 56a, PS1-<NUM> of cassette 56b, and/or PS1-<NUM> of cassette 56c, to which it is connected to ensure that solutions that should not be connected during a particular phase is not connected at that time. A response action may comprise the controller terminating the procedure, pausing the procedure, alerting the operator of the error, and/or prompting the operator to enter credentials for manual override.

Referring to <FIG>, in a source fluid drawing phase of the fluid processing procedure subsequent to priming, fluid may be drawn from a fluid source into the disposable kit <NUM> prior to separation. The fluid source may be a patient connected to access device <NUM>, or the fluid source may be from a source container such as container <NUM> on hanger WS1. In one embodiment, anticoagulant may be mixed with the source fluid prior to entering processing chamber <NUM> for separation. <FIG> depicts an anticoagulant container <NUM> associated with hanger WS5 and connected to cassette 56b and its pressure sensor PS2 via a fluid path comprising tubing <NUM> and valve <NUM> of cassette 56b. The hanger WS5 may also be a weight scale configured to measure the weight of container <NUM> and provide input to the controller. The drawing phase of one embodiment of the fluid processing procedure may be associated with, e.g., a <NUM> volume of anticoagulant for mixing with the source fluid. The controller may be configured to check that the initial weight reading at hanger WS5 at the beginning of the drawing phase is within a programmed range, e.g., approximately <NUM> to <NUM> grams for a <NUM> anticoagulant solution. The controller may also be configured to monitor and detect a gradual decrease in weight readings at hanger WS5 and, in the case of source fluid being drawn from a donor/patient, no changes in weight readings at other hangers WS1-<NUM> during the drawing phase as a confirmation measure that anticoagulant is actually exiting the container <NUM> on hanger WS5 as intended. In an embodiment in which the source fluid is being drawn from a container, e.g., container <NUM> on hanger WS1, the controller may also be configured to detect a second gradual decrease in weight readings at hanger WS1.

Throughout the drawing phase, the controller may also be configured to receive input from pressure sensor PS2 of cassette 56b to which container <NUM> may be in fluid communication when the drawing phase has initiated. Receiving and checking input from the pressure sensor PS2 may provide a confirmation measure indicating that not only is the anticoagulant container <NUM> hanging on hanger WS5, but the anticoagulant container <NUM> is also properly connected to tubing <NUM> to be in fluid communication with the pressure sensor PS2 of cassette 56b. A confirmation measure for proper connection to tubing <NUM> may be advantageous for reasons described earlier, and the process by which the controller may receive hydrostatic pressure input from the pressure sensor PS2 of cassette 56b may likewise be similar to that described for the priming phase.

During the time when fluid communication is not initially established between container <NUM> and pressure sensor PS2, the pressure sensor PS2 may produce baseline pressure readings, e.g., reflective only of atmospheric pressure or a designated baseline pressure. At the start of the drawing phase, fluid communication may be established, e.g., by opening clamp <NUM> (<FIG>), and the pressure sensor PS2 may immediately measure an increased pressure due to the hydrostatic pressure of the anticoagulant solution. The controller may then be configured to compare the increased pressure against authorized pressure ranges programmed for the drawing phase and execute a response action if the increased pressure readings are not within the authorized ranges at specific times. The controller may also be configured to measure pressure at other pressure sensors, e.g., PS1-<NUM> of cassette 56a, PS1 and PS3-<NUM> of cassette 56b, and/or PS1-<NUM> of cassette 56c, to which it is connected to ensure that solutions that should not be connected during a particular phase is not connected at that time. A response action may comprise the controller terminating the procedure, pausing the procedure, alerting the operator of the error, and/or prompting the operator to enter credentials for manual override.

Referring to <FIG>, after the drawing phase, the source fluid may be separated within the chamber <NUM> into various components, some of which may be collected and/or returned to the donor. In this return and collection phase of the fluid processing procedure subsequent to separation, collected components may comprise platelets, RBCs, MNCs, plasma, and/or any combination of these. In one illustrative embodiment, platelets may be collected in container <NUM>, and remaining components may be returned to the donor. Additive solution in container <NUM> may be added to the collected platelets for storage, and as a safety requirement, the donor should be disconnected from the fluid circuit <NUM> before additive solution is added. <FIG> depicts an embodiment in which no weight scales are associated with containers <NUM> and <NUM>, although weight scales may be present. Containers <NUM> and <NUM> may be hung vertically above the cassette 56c. The platelet collection container <NUM> may be connected to pressure sensor PS4 of cassette 56c via a fluid path comprising tubing <NUM> and valve <NUM> of cassette 56c. The additive solution container <NUM> may be configured for connection to pressure sensor PS2 of cassette 56c via a fluid path comprising tubing <NUM> and valves <NUM> and <NUM> of cassette 56c. The return and collection phase may be associated with, e.g., simultaneous collection of platelets and remaining blood components to the donor, followed by disconnection of the donor from the kit <NUM>, followed by addition of <NUM> additive solution to the collected platelets. The controller may at the same time detect and confirm that there are no changes in weight readings at other hangers WS1-<NUM> during the return and collection phase in an embodiment in which, e.g., all other fluid components are being returned to the donor.

During the return and collection phase, the controller may be configured to receive input from pressure sensors PS4 and PS2 of cassette 56c. Receiving and checking input from the pressure sensor PS4 may provide a confirmation measure that the platelets are being properly routed into platelet container <NUM> and also provide an indication of the volume of platelets collected based on expected pressure readings associated with different volumes within container <NUM> of a known shape. At a time in which return of fluid to the donor is taking place, the controller may also receive input from the pressure sensor PS2 of cassette 56c and confirm that the additive solution is not connected to the pressure sensor PS2.

During the time when fluid communication is not initially established between container <NUM> and pressure sensor PS2 of cassette 56c, the pressure sensor PS2 may measure and confirm only baseline pressure readings. Once the donor has disconnected from the kit <NUM> and transfer of additive solution in container <NUM> to the platelets in container <NUM> is initiated, fluid communication may be established and the pressure sensor PS2 may immediately measure an increased pressure due to the hydrostatic pressure of the additive solution. The controller may then be configured to compare the increased pressure against authorized pressure ranges programmed for the <NUM> solution and confirm that the increased pressure reading is within the authorized ranges. The controller may then check that pressure at PS2 continues to increase as additive solution enters tubing <NUM> and increases the height of the liquid column contributing to P = ρgh. If the initial increased pressure at PS2 is not within authorized ranges and/or pressure at PS2 does not continuously increase according to authorized ranges at specific times, the controller may be configured to execute a response action, which may comprise the controller terminating the procedure, pausing the procedure, alerting the operator of the error, and/or prompting the operator to enter credentials for manual override. The controller may also be configured to measure pressure at other pressure sensors to which it is connected to ensure that solutions that should not be connected during a particular phase is not connected at that time.

Claim 1:
A bodily fluid processing system for monitoring fluid flow in a medical fluid procedure using hydrostatic pressure, comprising:
a hardware component (<NUM>) controlled by a programmable controller,
a fluid circuit (<NUM>) comprising a plurality of fluid pathways configured to mount and associate with the hardware component (<NUM>),
wherein the hardware component (<NUM>) comprises a pressure sensor (PS, PS1, PS2, PS3, PS4) in communication with the programmable controller and a fluid pathway;
the fluid circuit (<NUM>) includes a container (<NUM>, <NUM>, <NUM>, 41a, <NUM>) configured for fluid communication with the pressure sensor (PS, PS1, PS2, PS3, PS4) and configured to receive a volume of a fluid; and
the controller is configured to:
initiate a phase of the medical fluid procedure associated by the controller with a plurality of ranges of pressure values authorized at specific times for the pressure sensor (PS, PS1, PS2, PS3, PS4) ;
receive a first pressure value from the pressure sensor (PS, PS1, PS2, PS3, PS4) measured at a first time, when the container (<NUM>, <NUM>, <NUM>, 41a, <NUM>) is not in fluid communication with the pressure sensor (PS, PS1, PS2, PS3, PS4);
receive a second pressure value from the pressure sensor (PS, PS1, PS2, PS3, PS4) measured at a second time, when the container (<NUM>, <NUM>, <NUM>, 41a, <NUM>) is in fluid communication with the pressure sensor, with the second pressure value being indicative of hydrostatic pressure applied by the fluid within the container (<NUM>, <NUM>, <NUM>, 41a, <NUM>) and the fluid pathway ;
compare a difference between the second pressure value and the first pressure value to an authorized range of pressure values; and
execute a response action if the difference is not within the authorized range of pressure values.