Impella CP with SmartAssist
Abiomed, Inc. · Model 1000413
Impella CP with SmartAssist (Pump 382) pump set.
Intended use: A sterile tubular device with a built-in electrically-powered axial flow pump (e.g., a micro motor with an impeller) at the distal end, designed to provide circulatory assistance to the heart by pumping blood during heart failure. It is inserted through the lumen of the aorta and into the left ventricle, surgically or percutaneously via an artery, and connected to an external control unit; it moves blood from the left ventricle to the aorta across the aortic valve. It is typically used emergently post acute myocardial infarction (AMI), electively for high-risk cardiac catheterization, for open chest surgery, and during transport between hospitals. This is a single-use device.
Key tips
- ·When no category-specific guidance fits, default to the manufacturer's own service manual and the general troubleshooting method in the Engineer's Guide.
- ·Run an incoming and annual electrical safety test regardless of how niche the device is.
Typical Failure Modes
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Low or unstable pump flow / "Impella Flow reduced"
HighSymptoms: Flow drops below the set level, flow alarms, haemodynamic support falling.
Root cause: Pump position shifted (too far in / out or across the valve), suction from low LV volume, a kinked catheter, or a motor / rotor fault.
Purge-system fault
HighSymptoms: Purge pressure high or low, purge-flow alarm, purge cassette fault.
Root cause: Purge cassette / tubing occlusion or air, wrong purge-fluid concentration, or a purge-pump fault in the controller.
Placement-signal / position-monitoring fault
HighSymptoms: Damped or absent placement (aortic) pressure waveform, "Impella position unknown".
Root cause: Optical / pressure sensor in the catheter, air in the pressure lumen, or a catheter-connector fault.
Controller (AIC) fault or battery issue
MediumSymptoms: Automated Impella Controller alarms, will not run on battery, screen or interface fault.
Root cause: Controller hardware fault or an aged controller battery.
Connector-cable / catheter-hub fault
MediumSymptoms: Intermittent motor current or signal, connection alarms.
Root cause: Worn catheter connector or the controller connector cable.
Serviceable Parts & Consumables
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
Automated Impella Controller (AIC) battery
Class Periodic replacementRel. cost $$$R&R Fairly easy
Purge cassette / tubing set
Single-use consumable.
Class ConsumableRel. cost $$R&R Easy
Connector / mobile-cable assembly
Class Periodic replacementRel. cost $$$R&R Easy
Impella catheter / pump set
Single-use; the pump/rotor is part of the catheter.
Class ConsumableRel. cost $$$$R&R Easy
AIC console (loaner / exchange)
Class Major service partRel. cost $$$$R&R Easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Automated Impella Controller (AIC) battery | Periodic replacement | $$$ | Fairly easy |
| Purge cassette / tubing set Single-use consumable. | Consumable | $$ | Easy |
| Connector / mobile-cable assembly | Periodic replacement | $$$ | Easy |
| Impella catheter / pump set Single-use; the pump/rotor is part of the catheter. | Consumable | $$$$ | Easy |
| AIC console (loaner / exchange) | Major service part | $$$$ | Easy |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Follow the manufacturer's PM schedule
- ·Perform incoming and annual electrical safety testing per facility biomedical program
Troubleshooting Approach
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Low flow / flow alarm
- This is an OEM-supported system - clinical management is by the care team; a BMET supports the controller and accessories, never the sterile field.
- On the AIC, check the flow, motor current and placement-signal displays together.
- The care team assesses catheter position (echo / fluoro) and LV volume for suction.
- Check the catheter for a kink outside the body and the connector cable seating.
- If the controller flags a motor / hardware fault, swap to a backup AIC and contact Abiomed.
Symptom: Purge-system alarm
- Check the purge cassette and tubing for occlusion, kinks or air.
- Confirm the purge fluid concentration and bag per the protocol.
- Follow the AIC's on-screen purge-troubleshooting prompts.
- Replace the purge cassette if the pressure will not normalise.
- Escalate a controller purge-pump fault to Abiomed and move to a backup AIC.
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- Yes
- Single use
- Yes
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Intracardiac circulatory assist axial-pump catheter
- FDA product classification
- Temporary Non-Roller Type Left Heart Support Blood Pump
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Varies by device - check the unit's own manual for facility placement guidance
Documents & Manuals
No documents available for this device yet.
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