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What This Guide Helps With
Suspected infusion-delivery inaccuracy involving setup, disposables, test configuration, tubing resistance, measurement technique, or pump performance.
Step-by-Step Troubleshooting
1. Protect the Patient and Remove the Pump From Use
If inaccurate delivery is suspected during patient therapy, replace the pump immediately with a verified device and notify appropriate clinical personnel. Do not continue using the affected pump while evaluating accuracy.
Expected outcome: Patient therapy is no longer dependent on a pump with questionable delivery performance.
2. Confirm the Reported Accuracy Problem
Determine whether the complaint concerns flow rate, total volume delivered, unexpectedly fast delivery, unexpectedly slow delivery, or disagreement with another measurement source.
Expected outcome: The reported condition and how it was determined are documented.
3. Inspect the Administration Set
Verify the correct approved administration set was used. Inspect for kinks, stretching, deformation, damaged cassette components, closed clamps, air, or incorrect loading.
Expected outcome: The disposable is correct, intact, and properly loaded. If a damaged or incorrectly loaded set explains the discrepancy, replace it and proceed to verification.
4. Check the Fluid Path and Container
Confirm the fluid source, tubing, filters, connectors, and downstream path are arranged correctly for the test or clinical setup and are not creating abnormal resistance.
Expected outcome: The fluid path is unrestricted and suitable for accuracy testing.
5. Verify Programmed Settings
Confirm the programmed rate, volume, dose-related parameters when applicable, and any secondary or piggyback configuration relevant to the complaint. Do not alter clinical records to make the observed result fit expectations.
Expected outcome: The pump was programmed as intended. A programming discrepancy identified as the cause should be documented appropriately.
6. Check the Measurement Method
Review how delivery accuracy was measured. Use approved infusion-device analyzer equipment, gravimetric methods, or other accepted test methods according to manufacturer and facility procedures.
Expected outcome: The measurement method is appropriate and the test equipment is within calibration.
7. Use a Known-Good Administration Set
Install a new compatible set from a known-good supply and repeat the measurement under controlled bench conditions.
Expected outcome: Delivery meets the applicable manufacturer or facility acceptance criteria. If the original set was responsible, troubleshooting can stop after complete verification.
8. Eliminate Setup Variables
Ensure tubing height, routing, backpressure, accessories, air, and test-equipment connections match the approved test configuration.
Expected outcome: The test setup itself is not causing an artificial accuracy error.
9. Repeat the Accuracy Test
Run the approved flow or volume-delivery test at the applicable test points required by your procedure. Do not invent tolerance limits or substitute informal timing methods for formal verification.
Expected outcome: Results fall within the specified acceptance criteria.
10. Compare With Another Verified Pump if Needed
When the test setup itself remains in question, test a known-good Ivenix pump with the same analyzer, tubing configuration, and disposable type.
Expected outcome: The comparison confirms whether the discrepancy follows the pump or test setup.
11. Check Repeatability
If the pump initially passes after correction, repeat testing as required by the applicable procedure to ensure the result is stable rather than intermittent.
Expected outcome: Delivery remains consistently within the approved acceptance criteria.
12. Perform Complete Return-to-Service Testing
After any corrective action, complete all applicable infusion performance, alarm, battery/power, and electrical safety testing required by facility and manufacturer procedures.
Expected outcome: The pump passes all required tests. If accuracy remains outside tolerance, it must stay out of service.
If the Problem Persists
Incorrect disposables, loading problems, tubing restrictions, programming discrepancies, measurement errors, and test-setup variables have been ruled out. Persistent out-of-tolerance delivery may involve the pumping mechanism, sensing system, mechanical wear, calibration, or another internal service-level condition.
Remove the device from service, label it Out of Service, and send it for repair or bench evaluation. Use approved Fresenius Kabi service documentation and calibrated test equipment. Calibration or internal mechanical repair should be performed only by qualified personnel.
Do not return the pump to clinical use until formal accuracy and complete return-to-service testing pass.
Knowing when to stop external troubleshooting is proper troubleshooting.
Clinical Use Tip
Any credible report of inaccurate infusion delivery should be treated as a patient-safety issue until objective testing proves the pump is within approved criteria.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Nursing reported that an Ivenix pump appeared to deliver a programmed infusion more slowly than expected."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the administration tubing was sharply kinked below the pump, and bench accuracy testing with a new properly routed set was within the approved acceptance criteria."
Resolution
What action was taken.
Example:
"Replaced and correctly routed the administration set, completed required infusion accuracy and functional testing, and returned the pump to service."
Helpful Details to Include (If Known)
- Reported rate or volume discrepancy
- Programmed settings
- Administration set type
- Tubing or clamp condition
- Fluid-path accessories
- Test equipment used
- Test equipment calibration status
- Approved acceptance criteria referenced
- Known-good set results
- Known-good pump comparison
- Repeatability results
- Final performance testing
- Final device status
Final Thought
Accuracy concerns require objective measurement, not assumption. Verify the disposable, fluid path, programming, and test method first, then escalate any pump that cannot meet approved performance criteria.
That is successful troubleshooting.