Getinge ROTAFLOW II

Drive Unit Does Not Recognize the Pump Head

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Asset Type

Extracorporeal Membrane Oxygenation (ECMO) System

Manufacturer

Getinge

Model

ROTAFLOW II

What This Guide Helps With

Troubleshoots pump-head recognition problems involving installation, compatibility, contamination, damage, drive connection, and external mechanical alignment.

Step-by-Step Troubleshooting

1. Protect the Patient and Maintain ECMO Support

Do not troubleshoot pump-head recognition on the drive currently sustaining a patient. Maintain extracorporeal support through the established ECMO backup process before manipulating the pump head or drive.

Expected outcome: Patient support remains stable and the suspect equipment is available for safe, non-patient evaluation.

2. Confirm the Recognition Problem

Determine whether the drive:

Record the exact behavior before changing components.

Expected outcome: The recognition failure is clearly defined and can be reproduced safely.

3. Verify the Pump Head Is Correctly Installed

Inspect the pump head and confirm it is fully seated in the drive using normal installation technique. Check that:

Do not force the pump head into place.

Expected outcome: Proper installation results in stable recognition. If reseating resolves the condition, proceed to final verification.

4. Inspect for Contamination or Physical Damage

Remove the pump head only in an appropriate non-patient setup. Inspect accessible mating areas for:

Follow approved cleaning procedures for reusable equipment.

Expected outcome: The pump head and drive interface are clean and physically intact. Damaged components are not returned to service.

5. Verify Component Compatibility

Confirm the pump head and associated circuit components are approved for use with the ROTAFLOW II configuration being evaluated.

Do not attempt to make an incompatible component function by altering the drive or system configuration.

Expected outcome: The installed pump head is an appropriate compatible component.

6. Test With a Known-Good Compatible Pump Head

Using a safe bench or training setup, install a known-good compatible pump head when available.

Compare recognition behavior without changing unrelated configuration.

Expected outcome: If the known-good pump head is recognized consistently, the original pump head or its installation is implicated. If neither is recognized, continue troubleshooting the drive system.

7. Inspect Drive Connections

Confirm the drive unit is properly connected to the console and inspect accessible cables and connectors for:

Do not flex or manipulate a damaged cable to keep the device operational.

Expected outcome: Drive connections remain secure and recognition is stable.

8. Verify Console Startup and Basic Drive Operation

Confirm the console completes startup normally and does not display broader drive or system faults that could explain the recognition problem.

Avoid unauthorized service or configuration changes.

Expected outcome: Console and drive initialize normally except for the specific reported recognition issue.

9. Perform Final Functional Verification

After correction, confirm:

Expected outcome: Pump-head recognition and pump operation are repeatable and reliable. Troubleshooting can stop.

10. Escalate an Unresolved Recognition Failure

If multiple known-good compatible pump heads are not recognized despite proper installation and secure external connections, stop external troubleshooting.

Expected outcome: The unit is removed from service for drive-interface or internal system evaluation.

If the Problem Persists

Common pump-head installation, compatibility, contamination, damage, and connection causes have been ruled out. A persistent failure may involve the drive unit, sensing or recognition mechanism, internal communication, or system electronics.

The device should be:

Complete required pump-drive, recognition, alarm, and system functional testing before release following repair.

Knowing when to stop external troubleshooting is proper troubleshooting.

Clinical Use Tip

Do not manipulate or exchange an ECMO pump head supporting a patient unless it is part of the clinical team's established circuit-management and emergency procedure.

Work Order Documentation (CCR Method)

CCR = Complaint, Cause, Resolution

Complaint

What was reported by the clinical staff.

Example:
"ECMO staff reported the ROTAFLOW II drive would not consistently recognize the pump head during setup."

Cause

What was observed during troubleshooting.

Example:
"Clinical Engineering found the pump head incompletely seated because tubing tension was pulling the head away from the drive interface."

Resolution

What action was taken.

Example:
"Corrected tubing positioning, fully seated the pump head, verified consistent recognition and stable pump operation on a test setup, and returned the system to service."

Helpful Details to Include (If Known)

Final Thought

Protect patient support first, verify installation and compatible external components before suspecting the drive, use controlled comparison testing, and escalate persistent recognition failures appropriately.

That is successful troubleshooting.

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