University of Pittsburgh



Initial Hazard Analysis

Intravenous Infusion Simulation

Russell Bregman, Jon Grasman, Craig Lehocky, Adam Scharl

Advisor: Dr. Joe Samosky

April 22, 2008

Revision 4

 

Purpose: To identify possible hazards associated with the use of the Intravenous Infusion Simulation (IVIS). This document examines the potential hazards associated with the flow sensors, IV tubing and connections, the visual feedback mechanism, the causes of such hazardous conditions, and the system’s intended response.

The greatest hazard posed by our design is our device providing an inaccurate simulation and incorrect training of the user, otherwise known as a negative training effect. As a simulation device, the IVIS must accurately and reliably measure and display appropriate flow parameters in order for the user to gauge his or her own accuracy with regards to the rate of infusion when administering drugs. This will ultimately be translated to live patient conditions, and therefore any steps that the user must take outside of what would be done in normal proceedings in a medical setting must be avoided. Thus, all of the hazards that are analyzed below fall under the single greatest hazard of this device: inaccurate user training.

Table 1 identifies the possible risks associated with hazards and the associated number for that risk (as used in Potential Hazards) to classify each hazard with an assignment of risk.

Table 1. Legend: Interpreted Risk Levels

|Risk Level |Interpretation |

|1 |Intolerable Risk |

|2 |Undesirable Risk |

|3 |Tolerable Risk |

|4 |Negligible Risk |

Potential Hazards (Associated Risk Level)

1. Incorrect flow rate measurement. (2)

2. Incorrect volume, concentration or flow visual feedback. (2)

3. Physical harm to user. (4)

4. Inoperable system. (1)

5. Unrealistic simulation. (3)

Potential Causes of Hazards

1. Fluid leak between syringe and infusion port leading to incorrect measurement. Improper cleaning or calibration of system. Flow sensor malfunction. Data acquisition unit error.

2. Programming error. Faulty hardware-software communication or calibration. Incorrect drug input (wrong initial value of drug concentration). LED display malfunction. Data acquisition unit error.

3. Fluid leak onto floor due to broken IV line or flow sensor components, leading to slipping or falling. Electric shock from fluid contacting electrical components. Potential entanglement in electrical wiring or IV tubing.

4. Power failure. Incorrect user assembly of device. Data acquisition software or hardware termination.

5. Inaccurately designed infusion site that does not mimic actual IV conditions. Unrealistic precautions taken by the user to avoid electrical components and wiring of the sensor. Incomparable physical appearance to typical IV setup.

  System’s Intended Response

1. An incorrect flow measurement due to a fault with one flow sensor is recognized by the data acquisition unit. Flow data acquired from the two-sensor design confirms correct or incorrect measurements from the flow sensors by calculating a mass balance. Maximum and minimum flow parameters assigned to each drug provide allowable ranges for the data acquisition unit. If the flow is measured to exceed this allowable range, the data acquisition unit provides the user with a visual warning.

2. Similarly, the data acquisition unit is provided with acceptable tolerances for delivered volume values for each drug. If the measured volume exceeds this range, the data acquisition unit provides the user with a visual warning. The data acquisition unit reports a visual warning if any of the LEDs malfunction, shorting the circuit and not returning a voltage to the DAQ.

3. A fluid leak will result in the data acquisition unit recognizing flow measurement errors, resulting in visual feedback to the user. Ergonomic design of the infusion site sensor casing should allow for the same infusion techniques as a standard infusion F-site.

4. The data acquisition software will handle power surges by shutting down the system if received voltages exceed a maximum value.

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