Model note · Cardiopulmonary Bypass
Terumo Advanced Perfusion System 1
System 1 is a modular heart-lung machine used by perfusionists for cardiopulmonary bypass, arterial perfusion and regional perfusion for up to six hours. Roller pumps, centrifugal pumps, sensor modules and an electronic gas blender all sit on a CAN network and are set up and controlled from a 15 inch central touchscreen. Its defining traits are the distributed network design, configurable safety responses that link sensors to pumps, and an internal battery rated for at least 60 minutes.
The model
Maker, model and type.
- Maker
- Terumo Cardiovascular Systems Corporation
- Model
- Advanced Perfusion System 1 (System 1), bases 801763 and 801764
- Device type
- Cardiopulmonary Bypass
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Base voltage | 100/120 V or 220/240 V, 50/60 Hz (catalogue 801763 and 801764) | Source |
| Base size and weight | 57.4 x 89.4 x 67.3 cm (H x W x D), 118.8 kg | Source |
| Pumps supported | Up to eight pumps, including up to two centrifugal control units | Source |
| Roller pumps | 4 inch head, 0 to 4 L/min; 6 inch head, 0 to 10 L/min | Source |
| Centrifugal control unit range | 0 to 3,600 RPM | Source |
| Monitoring modules | Up to 18 modules (pressure, temperature, flow, level, air bubble, occluder, interface) | Source |
| Pressure module range | -250 to 900 mmHg, two transducers per module | Source |
| Air bubble detector sensitivity | 0.5 cc or larger up to 6 L/min on 3/8 inch tubing; 0.3 cc or larger up to 3 L/min on 1/4 inch tubing | Source |
| Electronic gas blender | 0 to 10 L/min gas flow, FiO2 0.21 to 1.00 | Source |
| Battery backup | At least 60 minutes for a fully loaded system when fully charged; up to 13 hours to recharge | Source |
| Indicated duration | Up to six hours of extracorporeal circulation | Source |
Recalls
Known FDA recalls.
- Z-1108-20202020-01-10
Roller pump shafts may fail at the locknut thread, preceded by atypical noise.
FDA record - Z-0176-20192018-09-13
EPGS service manual was not updated when software 1.30 was released.
FDA record - Z-0435-20132012-11-14
Reports of total loss of function where some units went blank.
FDA record - Z-1320-20122012-03-16
6 inch roller pump jammed during cardioplegia delivery in 27 reported instances.
FDA record - Z-1224-20092009-01-12
Central Control Monitor start-up failure, display and calibration problems, loss of function.
FDA record - Z-0909-20092008-11-07
Power manager board could short, causing loss of power, loss of monitor or arcing.
FDA record
Safety
Safety warnings from the record.
- A partly charged battery may give less than 60 minutes of backup for a fully loaded system. Source
- Battery time falling faster than real time, or a red battery icon after returning to mains, indicates damaged or discharged batteries. Source
- When pumps lose the central computer they keep running locally but may not respond to linked sensor alarms such as air or level. Source
- Keep hand cranks and standby equipment ready, since several manual responses for pump errors rely on them. Source
- The 6 inch roller pump has jammed during cardioplegia delivery in reported cases. Source
Sources
Where this note comes from.
- Terumo, Advanced Perfusion System 1 Operator's Manual 90001314 rev H (eIFU)
- Terumo, System 1 brochure, February 2024
- Terumo, System 1 product page
- FDA 510(k) summary K221895
- openFDA recall search, Advanced Perfusion System
- openFDA MAUDE problem counts, Advanced Perfusion System 1
Not covered: The service manual is not public, so internal fault codes and calibration procedures are not covered; error entries come from the public operator's manual. Many recalls are older than 2013 and may already be corrected on most installed units.
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.
Cardiopulmonary Bypass
Other models of this device.
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