Standard Controlled Document Form
Number: |IHA - 1 |Revision: |2 | |
|Project: |Dual Port, Single Lumen IV Catheter |
|Title: |Initial Hazard Analysis |
|UNCONTROLLED DOCUMENT UNLESS ISSUED WITH A RED STAMP | |
|This document is the confidential property of the IV catheter group and may not be reproduced without prior |STAMP HERE |
|written consent | |
|Revision Approvals: |Date |
|Author |Kelly Baron, Riley Smith and Erik Frazier |4/29/2005 |
|Clinical |Sandra Gartner, RN, MSN |4/29/2005 |
|Engineering |Riley Smith |4/29/2005 |
|Quality Assurance |Kelly Baron and Erik Frazier |4/29/2005 |
|General Management |Kelly Baron, Riley Smith and Erik Frazier |4/29/2005 |
Purpose
1. To identify the hazards for the patient associated with the device
2. To determine the risk associated with each hazard
1. Scope
The following document lists the potential hazards of using the device along with the effects of the hazards and the risk associated with each. This document is to be used as a guide to limit the risks associated with the use of the IV to the patient.
References
1. Product Design Specification
2. Object Tree Analysis
3. FMEA
4. FMECA
Initial Hazard Analysis
5. Potential Hazards
6. Hazard Causes
7. Risk
8. System’s Intended Response
Revision History
9. IHA- 1; Revision 2; 4/29/2005
1. Changed specifications to Dual-Port Single-Lumen design
2. Changed interactions to reflect design change
Initial Hazard Analysis
Potential Hazards:
• Infection of the skin around the catheter or port
• Must stick vein again with needle
• Misdiagnosis
• No fluid delivery to patient
Hazard Causes:
• Blood clot in the tubing inhibiting flow in either direction
• Kinking of tubing
• Flow blocked by valves or walls of vein
• Inaccurate blood test results
• Non-sterile insertion into vein
• Blood mixing with fluids being given
• Mechanical breakage
Risk:
• Central line- High Risk
o General anesthesia
o Insertion through subclavian vein
▪ Possible lung puncture
▪ Must be done by surgeon- costly
o Long term
• Peripheral line- Low risk
o Insertion through anacube vein in arm
o Can be done by IV team or trained nurses/technicians
o Can be central or midline
o Short term
System’s Intended Response:
• Any problems need to be recognized by nurse or technician on duty
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