Education

Case serial: SCH-2021-05
Title: Tubing line for dialyzer

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 24 44.4%
A A05 - Lower Level Codes 6 11.1%
A A14 - Lower Level Codes 5 9.3%
A A07 - Lower Level Codes 4 7.4%
A A04 - Lower Level Codes 4 7.4%
A A08 , A01 , A06 , A12 , A13 , A20 , A24 11
total:54
20.4%
B B02 - Lower Level Codes 16 39.0%
B B01 - Lower Level Codes 7 17.1%
B B04 - Lower Level Codes 5 12.2%
B B05 - Lower Level Codes 5 12.2%
B B03 - Lower Level Codes 4 9.8%
B B06 , B07 , B14 , B17 4
total:41
9.8%
C C16 - Lower Level Codes 13 38.2%
C C07 - Lower Level Codes 10 29.4%
C C06 - Lower Level Codes 4 11.8%
C C04 - Lower Level Codes 2 5.9%
C C13 - Lower Level Codes 1 2.9%
C C17 , C01 , C03 , C05 4
total:34
11.8%
D D03 - Lower Level Codes 25 69.4%
D D02 - Lower Level Codes 4 11.1%
D D05 - Lower Level Codes 2 5.6%
D D17 - Lower Level Codes 1 2.8%
D D18 - Lower Level Codes 1 2.8%
D D01 , D08 , D16 3
total:36
8.3%
E E24 - Lower Level Codes 14 48.3%
E E13 - Lower Level Codes 5 17.2%
E E03 - Lower Level Codes 3 10.3%
E E21 - Lower Level Codes 2 6.9%
E E01 - Lower Level Codes 1 3.4%
E E02 , E09 , E11 , E20 4
total:29
13.8%
F F05 - Lower Level Codes 13 39.4%
F F26 - Lower Level Codes 10 30.3%
F F27 - Lower Level Codes 4 12.1%
F F01 - Lower Level Codes 2 6.1%
F F04 - Lower Level Codes 2 6.1%
F F03 , F09 2
total:33
6.1%
G G04 - Lower Level Codes 17 51.5%
G G06 - Lower Level Codes 6 18.2%
G G07 - Lower Level Codes 5 15.2%
G G01 - Lower Level Codes 2 6.1%
G G05 - Lower Level Codes 1 3.0%
G G02 , G03 2
total:33
6.1%

real case . frequent case.

Soo Jeong Choi , Republic of Korea
[ 2021-09-04 09:06:42.0]

Thank you for good sharing.

[1]

Educational case

Jaeyeong Jang , Republic of Korea
[ 2021-09-11 10:50:03.0]

this happens frequently in clinical situation.

[1]

Real Incident

Aidahwaty Olaybal , Malaysia
[ 2021-09-11 18:09:10.0]

It frequent happen in clinical situation.

[1]

Material qualty

María Eugenia Villalobos-Hernández , (Non-APEC) Costa Rica
[ 2021-09-12 03:44:29.0]

Definitely the material should be always the best, we are dealing with human life, so this case is teaching a lot.

[1]

Hemodialysis system clinical adverse event

SoonWoo Hong , Republic of Korea
[ 2021-09-14 16:46:08.0]

It is helpful to be able to check actual adverse events

[0]

Tubing line for dialyzer

Stevie Lee , Republic of Korea
[ 2021-09-16 14:22:48.0]

It's very helpful activity

[0]

Tubing line for dialyzer

YoonSung Kim , Republic of Korea
[ 2021-09-16 17:50:12.0]

It's helpful to me

[0]

Manufacturing process problem identified

Jojor, S.Si., Apt., M.Si - , Indonesia
[ 2021-09-16 23:46:07.0]

it is possible that the problem is in the manufacturing process, caused the problem can be solved with another tubing with different lot

[0]

Tubing line for dialyzer

Anita Nf , Indonesia
[ 2021-09-20 02:44:30.0]

This activity is helpful to learn adverse event

[0]

Manufacturing process problem identified

Erika Masis , (Non-APEC) Costa Rica
[ 2021-09-20 12:12:42.0]

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]

Tubing line dialyzer

Aidahwaty Olaybal , Malaysia
[ 2021-09-22 23:02:56.0]

This activity is good to understand the problem of manufacturing.

[0]