Description
|
Patient Condition
- A 54-year-old female patient on standby for regular hemodialysis for end-stage renal disease.
- Nurse was setting up a tubing line and a dialyzer on the Hemodialysis system.
Events
- There was an alarm for error in pressure and connection from the Hemodialysis system, when started to prime the Hemodialysis system.
Post-event management & Health effect
- The problem was resolved by changing the tubing line and the dialyzer to a new product from a different lot.
- No significant health complications occurred, but the patient complained about the delay.
Investigations (Cause, Improvements)
- The investigator examined the tubing lines from the same lot and found micro-holes from the tubing line, which may have occured due to abnormalities in the mold during the manufacturing process.
- Recall all tubing lines of the same lot, check the manufacturing process, take corrective actions and preventive actions.
|
Annex
|
Code
|
#
|
%
|
A |
A02 - Lower Level Codes
A02 |
Manufacturing, Packaging or Shipping Problem |
16 |
|
A0201 |
Product Quality Problem |
2 |
|
A020102 |
Nonstandard Device |
2 |
|
A0202 |
Defective Component |
3 |
|
A0203 |
Defective Device |
1 |
|
|
24
|
44.4%
|
A |
A05 - Lower Level Codes
A05 |
Mechanical Problem |
3 |
|
A0504 |
Leak/Splash |
2 |
|
A0509 |
Physical Resistance/Sticking |
1 |
|
|
6
|
11.1%
|
A |
A14 - Lower Level Codes
A14 |
Infusion or Flow Problem |
2 |
|
A1403 |
Filling Problem |
1 |
|
A141101 |
Decrease in Pressure |
1 |
|
A141402 |
Incomplete or Inadequate Priming |
1 |
|
|
5
|
9.3%
|
A |
A04 - Lower Level Codes
A04 |
Material Integrity Problem |
1 |
|
A0401 |
Break |
1 |
|
A041001 |
Material Puncture/Hole |
1 |
|
A0415 |
Scratched Material |
1 |
|
|
4
|
7.4%
|
A |
A07 - Lower Level Codes
A07 |
Electrical /Electronic Property Problem |
4 |
|
|
4
|
7.4%
|
A |
A01 , A08 , A20 , A24 , A06 , A12 , A13 |
11 total:54
|
20.4%
|
B |
B02 - Lower Level Codes
B02 |
Testing of Device from Same Lot/Batch Retained by Manufacturer |
16 |
|
|
16 |
39.0%
|
B |
B01 - Lower Level Codes
B01 |
Testing of Actual/Suspected Device |
7 |
|
|
7 |
17.1%
|
B |
B04 - Lower Level Codes
B04 |
Testing of Device from Other Lot/Batch Retained by Manufacturer |
5 |
|
|
5 |
12.2%
|
B |
B05 - Lower Level Codes
B05 |
Testing of Device from Other Lot/Batch Returned From User |
5 |
|
|
5 |
12.2%
|
B |
B03 - Lower Level Codes
B03 |
Testing of Device from Same Lot/Batch Returned from User |
4 |
|
|
4 |
9.8%
|
B |
B06 , B07 , B14 , B17 |
4 total:41 |
9.8%
|
C |
C16 - Lower Level Codes
C16 |
Manufacturing Process Problem Identified |
10 |
|
C1601 |
Assembly Problem Identified |
2 |
|
C1603 |
Installation Problem Identified |
1 |
|
| 13 |
38.2%
|
C |
C07 - Lower Level Codes
C07 |
Mechanical Problem Identified |
5 |
|
C0703 |
Leakage/Seal |
4 |
|
C0707 |
Incorrect Dimension |
1 |
|
| 10 |
29.4%
|
C |
C06 - Lower Level Codes
C06 |
Material and/or Chemical Problem Identified |
3 |
|
C0603 |
Inadequate Physicochemical Properties |
1 |
|
| 4 |
11.8%
|
C |
C04 - Lower Level Codes
C04 |
Interoperability Problem Identified |
1 |
|
C0402 |
Incompatible Component/ Accessory |
1 |
|
| 2 |
5.9%
|
C |
C01 - Lower Level Codes
C01 |
Biological Problem Identified |
1 |
|
| 1 |
2.9%
|
C |
C03 , C05 , C13 , C17 |
4 total:34 |
11.8%
|
D |
D03 - Lower Level Codes
D03 |
Cause Traced to Manufacturing |
9 |
|
D0301 |
Manufacturing Deficiency |
9 |
|
D0302 |
Quality Control Deficiency |
7 |
|
| 25 |
69.4%
|
D |
D02 - Lower Level Codes
D02 |
Cause Traced to Component Failure |
4 |
|
| 4 |
11.1%
|
D |
D05 - Lower Level Codes
D05 |
Cause Traced to Infrastructure |
2 |
|
| 2 |
5.6%
|
D |
D08 - Lower Level Codes
D08 |
Cause Traced to Training |
1 |
|
| 1 |
2.8%
|
D |
D16 - Lower Level Codes
D16 |
Conclusion Not Yet Available |
1 |
|
| 1 |
2.8%
|
D |
D17 , D18 , D01 |
3 total:36 |
8.3%
|
E |
E24 - Lower Level Codes
E24 |
Others |
3 |
|
E2403 |
No Clinical Signs, Symptoms or Conditions |
11 |
|
| 14 |
48.3%
|
E |
E13 - Lower Level Codes
E13 |
Kidney and Urinary Tract |
5 |
|
| 5 |
17.2%
|
E |
E03 - Lower Level Codes
E03 |
Blood and Lymphatic System |
2 |
|
E0303 |
Hemolysis |
1 |
|
| 3 |
10.3%
|
E |
E21 - Lower Level Codes
E21 |
Procedural Complications |
2 |
|
| 2 |
6.9%
|
E |
E11 - Lower Level Codes
E11 |
Hepatic and Biliary System |
1 |
|
| 1 |
3.4%
|
E |
E20 , E01 , E02 , E09 |
4 total:29 |
13.8%
|
F |
F05 - Lower Level Codes
F05 |
Delay to Treatment/ Therapy |
13 |
|
| 13 |
39.4%
|
F |
F26 - Lower Level Codes
F26 |
No Health Consequences or Impact |
10 |
|
| 10 |
30.3%
|
F |
F27 - Lower Level Codes
F27 |
No Patient Involvement |
4 |
|
| 4 |
12.1%
|
F |
F01 - Lower Level Codes
F01 |
Change in Therapeutic Response |
2 |
|
| 2 |
6.1%
|
F |
F04 - Lower Level Codes
| 2 |
6.1%
|
F |
F03 , F09 |
2 total:33 |
6.1%
|
G |
G04 - Lower Level Codes
G04 |
Mechanical |
7 |
|
G04069 |
Hose |
2 |
|
G04105 |
Pump |
1 |
|
G04134 |
Tube |
7 |
|
| 17 |
51.5%
|
G |
G06 - Lower Level Codes
G06 |
Safety |
3 |
|
G06001 |
Alarm |
3 |
|
| 6 |
18.2%
|
G |
G07 - Lower Level Codes
G07 |
Others |
3 |
|
G07001 |
Part/Component/Sub-assembly Term not Applicable |
1 |
|
G07002 |
Appropriate Term/Code Not Available |
1 |
|
| 5 |
15.2%
|
G |
G01 - Lower Level Codes
G01 |
Biological and Chemical |
2 |
|
| 2 |
6.1%
|
G |
G02 - Lower Level Codes
G02004 |
Cable, Electrical |
1 |
|
| 1 |
3.0%
|
G |
G03 , G05 |
2 total:33 |
6.1%
|
real case . frequent case.
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Soo Jeong Choi , Republic of Korea [ 2021-09-04 09:06:42.0]
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Thank you for good sharing.
[1]
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Educational case
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Jaeyeong Jang , Republic of Korea [ 2021-09-11 10:50:03.0]
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this happens frequently in clinical situation.
[1]
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Real Incident
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Aidahwaty Olaybal , Malaysia [ 2021-09-11 18:09:10.0]
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It frequent happen in clinical situation.
[1]
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Material qualty
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María Eugenia Villalobos-Hernández , (Non-APEC) Costa Rica [ 2021-09-12 03:44:29.0]
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Definitely the material should be always the best, we are dealing with human life, so this case is teaching a lot.
[1]
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Hemodialysis system clinical adverse event
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SoonWoo Hong , Republic of Korea [ 2021-09-14 16:46:08.0]
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It is helpful to be able to check actual adverse events
[0]
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Tubing line for dialyzer
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Stevie Lee , Republic of Korea [ 2021-09-16 14:22:48.0]
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It's very helpful activity
[0]
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Tubing line for dialyzer
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YoonSung Kim , Republic of Korea [ 2021-09-16 17:50:12.0]
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It's helpful to me
[0]
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Manufacturing process problem identified
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Jojor, S.Si., Apt., M.Si - , Indonesia [ 2021-09-16 23:46:07.0]
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it is possible that the problem is in the manufacturing process, caused the problem can be solved with another tubing with different lot
[0]
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Tubing line for dialyzer
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Anita Nf , Indonesia [ 2021-09-20 02:44:30.0]
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This activity is helpful to learn adverse event
[0]
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Manufacturing process problem identified
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Erika Masis , (Non-APEC) Costa Rica [ 2021-09-20 12:12:42.0]
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Problems with a device that can be traced to a problem in the manufacturing and/or production process, ej. in the tubing line for dialyzer.
[1]
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Tubing line dialyzer
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Aidahwaty Olaybal , Malaysia [ 2021-09-22 23:02:56.0]
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This activity is good to understand the problem of manufacturing.
[0]
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