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What This Guide Helps With
Troubleshoots reagent-transfer, waste, drainage, tubing, container, leakage, and external fluidics conditions that prevent normal tissue processing.
Step-by-Step Troubleshooting
1. Protect Specimens and Control Chemical Hazards
If specimens are being processed, involve laboratory staff immediately to protect them. If liquid is leaking, follow facility chemical-safety procedures and keep personnel away from the spill as appropriate.
Do not continue operating equipment with uncontrolled leakage.
Expected outcome: Specimens and personnel are protected before fluidics troubleshooting begins.
2. Record the Exact Fault
Capture the complete displayed fluidics, waste, or wash-related message and identify when it occurred in the processing cycle.
Determine whether the processor stopped, paused, or continued operating.
Expected outcome: The specific fluidics condition and point of failure are known.
3. Inspect for External Leakage
Visually inspect around the processor, reagent containers, accessible tubing, fittings, and waste containers for wetness, dripping, pooling, damaged containers, or chemical residue.
If significant leakage is present, remove the processor from service.
Expected outcome: No uncontrolled leak is present. Any leak discovered is contained and appropriately escalated.
4. Verify Reagent and Waste Containers
Confirm that required reagent and waste containers are present, correctly positioned, properly connected, and not obviously overfilled, empty, damaged, or misidentified.
Expected outcome: Containers are correctly installed and suitable for operation.
5. Inspect Accessible Tubing and Fittings
Check external or routinely accessible tubing for kinks, compression, loose connections, visible obstruction, cracking, or improper routing.
Do not open internal fluid manifolds or valve assemblies.
Expected outcome: Accessible fluid paths are intact and unrestricted.
6. Check for External Obstructions
Inspect accessible drain, container, lid, and connection areas for paraffin, tissue debris, dried reagent, or other residue that may interfere with flow.
Clean only according to approved device and laboratory procedures.
Expected outcome: Accessible fluid pathways and interfaces are free of visible obstruction.
7. Verify Covers and Components Are Properly Positioned
Ensure that applicable lids, covers, containers, and removable processing components are fully installed.
A component that is not seated correctly can cause a fluidics or safety condition.
Expected outcome: All externally accessible components are correctly positioned.
8. Perform an Approved Fluidics Check
With specimens removed from risk and only if safe to proceed, perform an approved check of the affected fluidics function.
Observe for leakage, abnormal sound, failure to transfer fluid, or recurrence of the message.
Expected outcome: Fluid movement completes normally without leakage or warnings. If so, proceed to final verification.
9. Perform Final Verification
Confirm stable ready status and normal operation of the affected fluidics pathway before releasing the processor.
Expected outcome: The system completes the applicable fluidics function normally and is safe to return to service.
If the Problem Persists
If reagent and waste containers, accessible tubing, fittings, positioning, visible obstructions, and external leaks have been checked and the fault remains, common external causes have been ruled out.
Possible remaining causes include internal pumps, valves, pressure or vacuum systems, internal tubing, sensors, seals, control electronics, or internal contamination.
The device should be:
- Removed from service.
- Labeled Out of Service.
- Sent for repair or qualified service evaluation.
- Evaluated using appropriate Sakura Finetek documentation and approved test equipment.
- Repaired only by qualified personnel.
Do not operate the processor with uncontrolled leakage or unreliable fluid transfer. Complete appropriate leak and functional testing before return to service.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
Any fluidics fault that may change reagent exposure time or sequence should be treated as a specimen-integrity issue as well as an equipment problem.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Laboratory staff reported a fluidics fault and failure to complete the expected reagent-transfer portion of the processing cycle."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found an accessible waste connection improperly seated."
Resolution
What action was taken.
Example:
"The waste connection was correctly secured, the surrounding area was inspected for leakage, approved fluidics operation was verified, and the processor was returned to service."
Helpful Details to Include (If Known)
- Exact fault message
- Cycle stage when fault occurred
- Specimen status
- Reagent and waste container condition
- Tubing and fitting condition
- Evidence and location of leakage
- Visible obstruction or residue
- Functional test result
- Whether fault recurred
- Final device status
Final Thought
Protect specimens and personnel first, investigate containers, tubing, waste handling, and accessible fluid paths before assuming internal failure, and remove the processor from service whenever fluid transfer cannot be trusted.
That is successful troubleshooting.