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.