Getinge ROTAFLOW II

Bubble Detector Alarm or Sensor Test Failure

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Asset Type

Extracorporeal Membrane Oxygenation (ECMO) System

Manufacturer

Getinge

Model

ROTAFLOW II

What This Guide Helps With

Troubleshoots bubble alarms and failed sensor checks involving tubing placement, sensor contact, contamination, cabling, circuit condition, and external setup.

Step-by-Step Troubleshooting

1. Treat a Bubble Alarm as Clinically Significant

During ECMO support, do not assume a bubble alarm is false. Notify the clinical ECMO team immediately and follow the institution's air-management and ECMO emergency procedures.

Clinical staff must determine whether air is actually present and manage the patient-connected circuit.

Expected outcome: Potential air in the extracorporeal circuit is addressed clinically before technical troubleshooting begins.

2. Confirm Whether the Problem Is an Alarm or Test Failure

Determine whether the reported condition is:

Document the exact displayed message or behavior.

Expected outcome: The technical problem is distinguished from a genuine clinical bubble event.

3. Inspect Tubing Position in the Detector

On a safe setup, verify the intended tubing section is correctly positioned in the bubble detector.

Check for:

Expected outcome: Tubing sits securely and consistently in the intended sensing position. If correction restores normal detection, proceed to verification.

4. Inspect the Sensor Area for Contamination

Inspect accessible detector surfaces for:

Clean reusable surfaces only with approved methods.

Expected outcome: The detector interface is clean, dry, and undamaged.

5. Inspect Sensor Cable and Connections

Verify the detector cable is correctly connected and inspect it for cuts, pinching, connector damage, strain, or intermittent connection.

Expected outcome: The sensor remains recognized with a stable external connection.

6. Evaluate the Circuit Segment

On an approved test circuit, inspect the tubing segment passing through the detector for conditions that could interfere with sensing, including unusual surface condition, deformation, condensation, or inappropriate positioning.

Do not manipulate patient-connected tubing without the ECMO clinical team.

Expected outcome: The tubing segment is appropriate for reliable bubble detection.

7. Perform the Approved Sensor Test

Run only the normal user-accessible bubble-detector check or test specified for routine setup. Do not bypass or disable bubble detection to clear a failed test.

Expected outcome: The detector passes the approved test and returns to a normal monitoring state. If it does, continue to final verification.

8. Compare With Known-Good External Components

When available, use a known-good compatible detector cable, sensor assembly, or approved test setup as applicable without entering restricted service procedures.

Expected outcome: Comparison identifies whether the problem follows the external sensor component or remains with the system.

9. Perform Final Functional Verification

Before return to service, verify:

Expected outcome: Bubble detection is reliable and all required alarm functions pass. Troubleshooting can stop.

10. Escalate an Unresolved Detector Problem

If the test continues to fail or alarms occur without an explainable external cause, remove the equipment from service.

Expected outcome: The device is prevented from clinical use until qualified evaluation confirms reliable bubble detection.

If the Problem Persists

Tubing placement, contamination, external connections, sensor setup, and routine detector testing have been addressed. Remaining possibilities include the detector assembly, signal processing, internal communication, or another service-level problem.

The device should be:

Never bypass a bubble detector, suppress a persistent alarm, or return an ECMO system to service with unreliable air detection. Complete required alarm and detector verification following repair.

Knowing when to stop external troubleshooting is proper troubleshooting.

Clinical Use Tip

Any bubble alarm on a patient-connected ECMO circuit must be treated as a possible true air event until the clinical ECMO team determines otherwise.

Work Order Documentation (CCR Method)

CCR = Complaint, Cause, Resolution

Complaint

What was reported by the clinical staff.

Example:
"ECMO staff reported the ROTAFLOW II bubble detector failed its setup test before patient use."

Cause

What was observed during troubleshooting.

Example:
"Clinical Engineering found the circuit tubing was not fully seated in the bubble detector sensing area."

Resolution

What action was taken.

Example:
"Correctly positioned the tubing, repeated the approved detector test successfully, verified alarm operation, and returned the system to service."

Helpful Details to Include (If Known)

Final Thought

Protect the patient from possible circuit air first, verify the complete external sensing setup, never bypass an unreliable detector, and document both the identified cause and successful alarm verification.

That is successful troubleshooting.

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