Model note · ECMO
Maquet Cardiohelp System
Cardiohelp is a compact extracorporeal life support system: a portable drive unit that pumps blood through HLS disposables and monitors the circuit with built-in sensors. It is used for veno-venous or veno-arterial support in intensive care, cardiac surgery and cardiology, and is designed for transport inside and between hospitals by road or air. Its distinctive points are its small size, an integrated venous probe and a separate hand-driven Emergency Drive.
The model
Maker, model and type.
- Maker
- Maquet Cardiopulmonary GmbH (Getinge)
- Model
- Cardiohelp System (Cardiohelp-i drive unit)
- Device type
- ECMO
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Main components | Cardiohelp-i drive unit with integrated pump, controls and monitoring, plus a Cardiohelp Emergency Drive for manual operation | Source |
| Sensors and accessories | Flow/bubble sensor, level sensor, venous probe for blood gas and venous temperature, external temperature and pressure sensors | Source |
| Flow range by disposable | HLS Set Advanced 5.0: 0.5 to 5.0 l/min; HLS 7.0: 0.5 to 7.0 l/min | Source |
| Display | 5.7 inch touchscreen with rotary knob for flow and speed | Source |
| Battery | Integrated lithium-ion batteries, at least 90 minutes when fully charged | Source |
| Power inputs | Mains supply plus a DC device socket | Source |
| Interfaces | Alarm output (nurse call), USB type A and type B, equipotential bonding | Source |
| US indication | Circulatory and/or pulmonary support for up to six hours, in and outside hospital with the HLS/HIT Set Advanced | Source |
| FDA clearance | 510(k) K133598 (modified system, predicate K102726), product code DTQ | Source |
Recalls
Known FDA recalls.
- Z-1831-20242024-04-15
Patient leakage current in some devices well above expected levels.
FDA record - Z-0605-20242023-11-13
Breaks in insulation, shielding or wires of venous probe connection cables.
FDA record - Z-0555-20242023-11-06
IFU described some factory warning limits and bubble sensor defaults incorrectly.
FDA record - Z-0420-20242023-10-10
Possible blocking or impairment of the Emergency Drive.
FDA record - Z-0290-20242023-10-12
Weak weld could let the nut bolt break off the slide rail plate.
FDA record - Z-0082-20142013-09-12
Erroneous battery defective alarm with touchscreen backlight shutting down.
FDA record
Safety
Safety warnings from the record.
- A blocked Emergency Drive could leave the patient with too little blood flow if the main unit fails, with risk of ischaemia and hypoxia. Source
- Loss of venous probe data can lead to unsuitable flow, blood temperature or haemoglobin management. Source
- Some IFU versions described factory warning limits for venous and auxiliary pressure, and venous bubble sensor defaults, wrongly. Use the updated IFU. Source
- HLS Set Advanced disposables have been recalled for compromised sterile barriers; check lot numbers against notices. Source
Sources
Where this note comes from.
- Getinge, Cardiohelp System product page (Sweden, English)
- FDA 510(k) summary K133598, Cardiohelp System
- openFDA recall search, Cardiohelp
- openFDA MAUDE problem counts, Cardiohelp
Not covered: The public Cardiohelp-i IFU link returned not found, so the full alarm list, pump speed range, weight and dimensions could not be confirmed from a manufacturer document. Error messages listed are only those quoted in FDA recall records.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
ECMO