Model note · ECMO
Getinge ROTAFLOW centrifugal pump system
The ROTAFLOW is a Getinge centrifugal blood pump system with a console, a separate drive into which the single use RotaFlow pump head clips, and coated pump heads (BIOLINE or Softline). In the US the pump head is cleared as a component of an extracorporeal circuit used with the RotaFlow console for up to six hours (K090515). It is widely used in bypass and ECMO circuits. Its field record points to the connections and the power: a loose ODU plug or coaxial cable on the drive giving fluctuating flow readings, a console IFU with the wrong serial number cut over, and sterile barrier seal faults on BIOLINE pump heads. Its problem reports are led by incorrect messages, pumping stopped and battery problems.
The model
Maker, model and type.
- Maker
- Maquet Cardiopulmonary GmbH (Getinge)
- Model
- ROTAFLOW centrifugal pump system (console, drive 70102, RotaFlow pump heads BEQ-RF-32 / BO-RF-32)
- Device type
- ECMO
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA classification and clearances | Non roller type cardiopulmonary bypass blood pump, product code KFM; K991864 (2000, Jostra), K061072 (2006, Safeline), K090515 (18 December 2009, Softline coating) | Source |
| Indication and duration | Component of the extracorporeal circuit used with the RotaFlow Console; use restricted to six hours in the US labelling | Source |
| Coatings | BIOLINE (BEQ-RF-32) and Softline (BO-RF-32), Softline being the same coating as the QUADROX-i adult oxygenator | Source |
| Drive | ROTAFLOW Drive model 70102, connected to the console by an ODU plug and coaxial cable | Source |
| Console variants | US console 115 V / 60 Hz; consoles from serial 94175452 meet IEC 60601-1-2 4th edition | Source |
Recalls
Known FDA recalls.
- Z-0977-20242024-01-08
BIOLINE pump head seal nonconformities could compromise the sterile barrier.
FDA record - Z-2957-20202020-08-07
Console IFU gave the wrong serial number for the IEC 60601-1-2 4th edition change.
FDA record - Z-0678-20202019-12-03
Loose ODU plug or coaxial cable on the drive gives fluctuating flow values (11 units in the US).
FDA record - Z-1584-20192019-04-18
Support pack configuration could block EtO from parts of the fluid path.
FDA record
Safety
Safety warnings from the record.
Sources
Where this note comes from.
- FDA 510(k) K090515 summary, RotaFlow Centrifugal Pump with Softline Coating
- openFDA 510(k) records for Rotaflow
- openFDA device recall records for Rotaflow
- openFDA MAUDE problem counts for Rotaflow
Not covered: The console and drive manuals were not read, so speed and flow ranges, priming volume, battery time and alarm messages are not included. 'Widely used in bypass and ECMO circuits' and the RPM mode explanation are general perfusion knowledge, not quoted from Getinge; US use beyond six hours is outside the cleared labelling.
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