Failure Modes Effect Analysis (FMEA)

for Hemodialysis machine

Biomedical system design project

Name I.D
Khulood Alsamumi 202170354
Amal Oshaish 202170337
Roa'a Alfakeeh 202170238
Amna Shuga'a Alden 202170346
Zainab Alrajehi 202170341
Salsabeel Alshuga'a 202174107

Supervised By :
Dr. Khalil Al-khatab

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 ABSTRACT
A Failure Mode is the way in which the component,
subassembly, product, input, or process could fail to
perform its intended function. Helps us identify how
our process is most likely to fail.

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Table of Contents
ii ...................................................................................................................................... Abstract
iii…………………………………………….……………………………………………………………………Table of Contents

4 ..............................................................................................................What Is A Failure Mode

4 …………………………………………….…………………………………………………………………….……………… FMEA

5…………………………………………….………………….………………….…………… When to Conduct an FMEA?

5…………………………………………….………………….…………………….….………….…………… Types of FMEAs

5…………………………………………….………………….…………………….…..………….….…… FMEA Procedures

6…………………………………………….………………….…………………….….……………..….…… The FMEA Form

7…………………………………………….………………….…………..….…… Severity, Occurrence and Detection

7…………………………………………….………………….…………..….…………………………………… Rating Scales

8…………………………………………….………………….…………..….……………… Risk Priority Number(RPN)

8…………………………………………….…… Failure modes and effect analysis for hemodialysis machine

Table of figure
7 ....................................................................................................... figure1 Fmea Form
8 ............................................................................................Figure2 Fmea Explain Form
9 .................................................................... Figure 3 Severity,Occurrence And Detection

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What Is A Failure Mode?
A Failure Mode
 The way in which the component, subassembly, product,
input, or process could fail to perform its intended function
 Failure modes may be the result of upstream operations or
may cause downstream operations to fail.
 Things that could go wrong

FMEA
 Why
 Methodology that facilitates process improvement
 Identifies and eliminates concerns early in the development of
a process or design
 Improve internal and external customer satisfaction
 Focuses on prevention
 FMEA may be a customer requirement
 FMEA may be required by an applicable
Quality Management System Standard (possibly ISO)

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When to Conduct an FMEA?

Early in the process improvement investigation

When new systems, products, and processes are being
designed
When existing designs or processes are being changed
When carry-over designs are used in new applications
After system, product, or process functions are defined, but
before specific hardware is selected or released to
manufacturing

Types of FMEAs
 Design
1. Analyzes product design before release to production,
with a focus on product function
2. Analyzes systems and subsystems in early concept and
design stages
 Process
Used to analyze manufacturing and assembly processes
after they are implemented.

FMEA Procedures

1. For each process input (start with high value inputs),

determine the ways in which the input can go wrong
(failure mode)

2. For each failure mode, determine effects

 Select a severity level for each effect

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FMEA Procedures
3. Identify potential causes of each failure mode

 Select an occurrence level for each cause

4. List current controls for each cause

 Select a detection level for each cause

5. Calculate the Risk Priority Number (RPN)

6. Develop recommended actions, assign responsible persons, and
take actions

 Give priority to high RPNs

 MUST look at severities rated a 10
7. Assign the predicted severity, occurrence, and detection levels
and compare RPNs
The FMEA Form

figure1 Fmea Form |Page6

 Figure2 Fmea Explain Form

Severity, Occurrence and Detection

16) Severity
 Importance of the effect on customer
requirements
17) Occurrence
 Frequency with which a given cause occurs and
creates failure modes (obtain from past data if
possible)
18) Detection
 The ability of the current control scheme to detect
(then prevent) a given cause (may be difficult to
estimate early in process operations).
Rating Scales
 Severity
6 = Not Severe, 10 = Very Severe
 Occurrence
1 = Not Likely, 10 = Very Likely
 Detection
1 = Easy to Detect, 10 = Not easy to Detect
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High 10

Low 1
Figure 3 Severity,Occurrence And Detec on

RISK PRIORITY NUMBER(RPN)

 RPN is the product of the severity, occurrence, and detection
scores.

Failure modes and effect analysis for hemodialysis

machine
There are many failure occur in hemodialysis machine like pump,
sensors, tubes ,electrical or software errors and leaks in dialyzer or
tubes so, it is necessary maintain the hemodialysis machine
permanently.

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 Process / product
Failure modes and effect analysis form
FMEA
PROCESS /PRODUCT NAME HEMODIALYSIS MACHINE

RESPONSIBLE OUR TEAM

PREPARED BY OUR TEAM

FMEA DATE 1/4/2024

Process Steps Potential Potential S Potential O CURRENT D RP

/Input Failure Failure E Causes C CONTROLS E N
Mode Effects V C T
E U E
R R C
I R T
T E I
Y N O
C N
E
What Is the In What What Is the What What Are the
Process Step and Ways Does Impact on Causes Existing
Input Under the Key The Key the Key Controls and
Investigation? Input Go Output Input to Procedures
Wrong? Variables Go (Inspection
(Customer Wrong? and Test)
Requirements That Prevent
)? Either the
Cause or The
Failure
Mode?
Leaks in Tubing damage in Less efficiency 10 Damage in 0.9 Leaking test 1 9
tube /lose and it needs tube and (ultrasonic
connection more cost for lose sensor)
replacing tube connection
Leaks in Dialyzer damage in Less efficiency 7 Damage in 0.1 Damage in 1 0.7
dialyzer /lose and it needs dialyzer semi
connection more cost for and lose membrane
replacing connection
dialyzer
Blockages in Bend in tube Unsafe for 9 Bend in 0.9 Use clips to 2 8.1
Tubing device and tube fixing the tube
patient blood onto device
circle so, body,
necessary In addition,
monitor tube maintain its.
during operate

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 Process Steps Potential Potential S Potential O CURRENT D R
/Input Failure Mode Failure E Causes C CONTROL E P
Effects V C S T N
E U E
R R C
I R T
T E I
Y N O
C N
E
What Is the Process In What Ways What Is the What What Are
Step and Input Does the Key Impact on Causes the the Existing
Under Input Go The Key Key Input to Controls and
Investigation? Wrong? Output Go Wrong? Procedures
Variables (Inspection
(Customer and Test)
Requiremen That
ts)? Prevent
Either the
Cause or
The Failure
Mode?
Blockages in Dialyzer Blood clots Unsafe for 9 Blockage in 0 necessary 3 1
device and fibers of . replace it for 3.
patient blood dialyzer 5 every patient 5
circle
Failure in Pump Pressure/leakage Valve issues, 5 Up/down 0 Maintain 2 1.
/cavitation/ mechanical pressure/ . pump 3
temperature failure and leakage/vibra 1 permanently
internal tion 3
damage
Failure in Sensor thermal flow Device not 7 Short 0 Maintain 6 2
sensor/pressure operate circuit/mecha . sensors 1
sensor/air nical 5 permanently
detector sensor separation/ov
er heat or
pressure/wiri
ng damage
Electrical Issues Power problem Device not 2 Cables/wiring 0 Checkup 4 0.
operate damage . cables and 3
/power board 0 wiring /power 2
problems 4 board 0
permanently
Software Errors Defect in Device not 3 Setting 0 Take original 2 0.
program system operate problems/defe . program 1
ct In system 0 from 8
program 3 company 0
Alarms Errors Overheat/overlo Error 5 Over 0 Any massages 2 0.
ad/voltage error massages in heat/load/volt . go to catalog 1
detection screen and age error 0 for solve it.
device not wiring 1
operate problem

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 Actions Resp. Actions S O D RPN
Recommended Taken E C E
V C T
E U E
R R C
I R T
T E I
Y N O
C N
E
What Are the What are the
Actions for completed
Reducing the actions taken
Occurrence of with the
The Cause, Or recalculated
Improving RPN?
Detection?
monitor tubes/ Reduce Reduce in severity, 6 0.7 1 4.2
replace tube of Leaks in Occurrence and
patient blood Tubing same detection
circuit for every numbers
patient while
tube of
concentrate
solution
maintains it on
periods
Replace dialyzer Reduce Reduce in severity, 2 0.06 1 0.120
to every patient Leaks in Occurrence and
Dialyzer same detection
numbers
use clips to Reduce Reduce in severity, 4 0.7 1 2.8
fixing the Blockages Occurrence and
tube/maintain in Tubing reduce in detection
heparin pump numbers
Replace dialyzer Eliminate Reduce in severity, 2 0.03 1 0.060
to every patient Blockages Occurrence and
in reduce in detection
Dialyzer numbers
Maintain pump Reduce Reduce in severity, 2 0.09 1 0.180
permanently Failure in Occurrence and
and measure its Pump reduce in detection
inlet and outlets numbers
Maintain Reduce Reduce in severity, 3 0.2 3 1.8
sensors Failure in Occurrence and
permanently Sensor reduce in detection
and measure numbers
input & output
voltage

Checkup cables Reduce Reduce in severity, 0.5 0.01 2 0.010

and wiring Electrical Occurrence and
/power board Issues reduce in detection
permanently numbers
/change system

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of power 220or
112
Actions Resp. Actions S O D RPN
Recommended Taken E C E
V C T
E U E
R R C
I R T
T E I
Y N O
C N
E
What Are the What are the
Actions for completed
Reducing the actions taken
Occurrence of with the
The Cause, Or recalculated
Improving RPN‫؟‬
Detection‫؟‬
Take original Reduce Reduce in severity, 1.5 0.01 1 0.015
program and Software Occurrence and
setting device on Errors reduce in detection
environmental numbers
operation
Any massages go Reduce Reduce in severity, 2 0.008 1 0.016
to catalog for Alarms Occurrence and
solve it/read Errors reduce in detection
catalog before numbers
use device

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