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Case serial: SCH-2022-01-005
Title: Tubing line for dialyzer

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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.


  • 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.