Getinge ROTAFLOW II

Pressure Measurement Missing, Incorrect, or Unstable

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Asset Type

Extracorporeal Membrane Oxygenation (ECMO) System

Manufacturer

Getinge

Model

ROTAFLOW II

What This Guide Helps With

Troubleshoots absent, implausible, drifting, or unstable ECMO pressure measurements involving transducers, cables, tubing, zeroing, connections, and setup.

Step-by-Step Troubleshooting

1. Protect the Patient and Do Not Rely on Questionable Pressure Data

Inform the clinical ECMO team whenever circuit pressure information is missing or unreliable. Use approved alternate monitoring and clinical assessment as required.

Do not change patient-connected circuit connections solely to troubleshoot the monitor.

Expected outcome: Patient management continues without dependence on unreliable pressure values.

2. Confirm the Exact Pressure Problem

Identify:

Expected outcome: The affected channel and failure pattern are clearly documented.

3. Inspect the Pressure Transducer and Cable

Verify the appropriate pressure measurement accessory is connected correctly. Inspect accessible components for:

Expected outcome: The transducer and cable are secure and externally intact.

4. Inspect External Pressure Tubing and Connections

Clinical personnel should inspect patient-connected pressure lines for appropriate setup. On a bench setup, verify:

Expected outcome: The pressure pathway is correctly connected and mechanically intact.

5. Verify Transducer Position and Zeroing Conditions

Confirm the pressure transducer is positioned and zeroed according to the applicable clinical and manufacturer procedure.

Clinical personnel must establish the appropriate reference condition on a patient-connected circuit.

Do not compensate for an incorrect reading by applying undocumented offsets.

Expected outcome: Zeroing completes appropriately and the baseline is stable.

6. Check for Environmental or Mechanical Interference

Look for:

Expected outcome: The measurement setup remains mechanically stable.

7. Substitute a Known-Good Compatible Transducer or Cable

When appropriate, use a known-good compatible pressure transducer or cable on an approved non-patient test setup.

Do not exchange patient-connected circuit components without clinical coordination.

Expected outcome: If the problem follows the transducer or cable, remove that accessory from service. If it remains on the same channel, further system evaluation is required.

8. Compare Channel Behavior Under Controlled Test Conditions

Using approved test equipment, apply appropriate controlled pressure input when authorized by the manufacturer procedure and observe whether the measurement responds smoothly and consistently.

Do not perform unauthorized calibration.

Expected outcome: The displayed pressure responds consistently to controlled input and remains stable.

9. Perform Final Functional Verification

Verify:

Expected outcome: Pressure monitoring is reliable and repeatable. Troubleshooting can stop.

10. Escalate Persistent Pressure Measurement Failure

If known-good accessories, proper zeroing, secure connections, and controlled testing do not restore reliable pressure measurement, remove the system from service.

Expected outcome: Internal pressure-channel, communication, or processing problems are referred for qualified service evaluation.

If the Problem Persists

External transducer, tubing, connection, zeroing, positioning, and accessory causes have been ruled out. Remaining possibilities include an internal measurement channel, interface electronics, configuration, or communication failure.

The device should be:

After service, complete appropriate pressure-channel, alarm, system, and return-to-service verification before clinical use.

Knowing when to stop external troubleshooting is proper troubleshooting.

Clinical Use Tip

A plausible-looking ECMO pressure value can still be wrong; investigate any measurement that conflicts with circuit behavior, other monitoring, or the clinical picture.

Work Order Documentation (CCR Method)

CCR = Complaint, Cause, Resolution

Complaint

What was reported by the clinical staff.

Example:
"ECMO staff reported one ROTAFLOW II pressure channel displayed an unstable value during setup."

Cause

What was observed during troubleshooting.

Example:
"Clinical Engineering found the external pressure transducer cable connection partially disengaged at the monitor interface."

Resolution

What action was taken.

Example:
"Reseated the connection, verified stable zero and controlled pressure response with approved test equipment, completed alarm and functional checks, and returned the system to service."

Helpful Details to Include (If Known)

Final Thought

Protect the patient from unreliable monitoring, verify transducers, tubing, connections, and zeroing before assuming internal failure, and require stable verified measurements before return to service.

That is successful troubleshooting.

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