Case serial: SCH-2022-01-005
See the video for how to select your answer.
Title: Tubing line for dialyzer
- 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.
- 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.
Select the most appropriate IMDRF code for the description.