Smiths Medical Medfusion 3500

Preventive Maintenance or Calibration Test Failure

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Asset Type

Infusion Pump

Manufacturer

Smiths Medical

Model

Medfusion 3500

What This Guide Helps With

Troubleshoots PM or calibration failures caused by test setup, accessories, equipment, configuration, environmental conditions, or genuine performance problems.

Step-by-Step Troubleshooting

1. Keep the Pump Out of Clinical Service

A Medfusion 3500 that fails a required preventive-maintenance or calibration test should not be returned to patient use until the failure is understood and applicable acceptance requirements are met.

Expected outcome: The pump remains controlled by Clinical Engineering during evaluation.

2. Identify the Exact Failed Test

Document precisely which PM, calibration, safety, alarm, delivery, pressure, battery, or other required test failed. Record the actual measured result and the approved acceptance criterion from the applicable service documentation.

Expected outcome: The failure is defined by a specific test rather than a general statement that the pump "failed PM."

3. Verify the Test Procedure

Review the current approved procedure and make sure the correct setup, sequence, accessories, syringe type, environmental conditions, and test method were used. Do not invent or substitute undocumented limits.

Expected outcome: The test is being performed according to the correct current procedure.

4. Verify the Test Equipment

Confirm that the analyzer, meter, simulator, or other test equipment is appropriate, within its required calibration status, correctly configured, and functioning normally.

Expected outcome: The failed result is not caused by an unsuitable or incorrectly configured test instrument.

5. Inspect Cables, Fixtures, Syringes, and Accessories

Check all test connections and disposables for damage, leakage, restriction, incorrect sizing, loose fittings, or setup errors that could influence the measured result.

Expected outcome: The test setup is physically sound and uses appropriate known-good components.

6. Repeat the Test From a Fresh Setup

Rebuild the relevant test setup and repeat the failed test according to the approved procedure. Avoid repeatedly adjusting the pump simply to obtain a passing result.

Expected outcome: A setup-related failure clears, or the same performance failure is reproducible.

7. Compare With Known-Good Equipment

When practical, use a known-good syringe, accessory, test channel, cable, or analyzer input to isolate whether the abnormal result follows the pump or the test setup.

Expected outcome: The source of the discrepancy is narrowed to the device or external testing components.

8. Verify Required Configuration

Confirm that accessible pump configuration relevant to the test matches the applicable approved setup. Do not make unauthorized service-menu changes or alter clinical configuration merely to pass PM.

Expected outcome: The test is performed with the intended approved device configuration.

9. Perform Authorized Calibration Only When Required

If the manufacturer procedure calls for calibration and Clinical Engineering is authorized and equipped to perform it, follow the current approved documentation using suitable test equipment. Maintain the distinction between testing and calibration.

Expected outcome: The pump either meets the applicable criteria after authorized calibration or remains failed and requires escalation.

10. Escalate Any Unresolved PM Failure

If the pump repeatedly fails a required test after the setup and test equipment have been verified, do not return it to service. Escalate for qualified repair or manufacturer-directed evaluation.

Expected outcome: Only equipment that meets all required return-to-service criteria is released for clinical use.

If the Problem Persists

Test setup errors, accessories, analyzer configuration, environmental conditions, and applicable device configuration have been ruled out. The remaining cause may involve calibration drift, mechanical wear, sensing performance, power systems, alarm functions, software, or another internal service-level condition.

The device should be:

After corrective action, repeat the failed procedure and all other applicable return-to-service testing required by the manufacturer or facility program. Passing an unrelated functional test does not override a failed required PM test. Knowing when to stop and escalate is proper troubleshooting.

Clinical Use Tip

Never change a calibration or acceptance criterion merely to make a pump pass PM; verify the procedure, setup, and test equipment, then address the actual performance failure.

Work Order Documentation (CCR Method)

CCR = Complaint, Cause, Resolution

Complaint

What was reported by the clinical staff.

Example:
"The Medfusion 3500 failed its scheduled preventive-maintenance infusion performance test during Clinical Engineering inspection."

Cause

What was observed during troubleshooting.

Example:
"Clinical Engineering found that the test syringe used during the initial measurement was binding; the pump produced acceptable results with an appropriate known-good syringe."

Resolution

What action was taken.

Example:
"The test setup was corrected, the required PM tests were repeated successfully using approved test equipment, and the pump was returned to service."

Helpful Details to Include (If Known)

Final Thought

A PM failure should trigger verification of the procedure, setup, accessories, and test equipment before assuming internal failure. Release the pump only after required criteria are satisfied and the complete work is documented.

That is successful troubleshooting.

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