Model note · Haemodialysis Machine

Fresenius 2008T and 2008T BlueStar Hemodialysis Machine

Name: Fresenius 2008T and 2008T BlueStar Hemodialysis Machine
Brand: Fresenius 2008T

The Fresenius 2008T is a widely installed haemodialysis machine for acute and chronic dialysis in hospitals and dialysis clinics, controlling both the extracorporeal blood circuit and a volumetric dialysate circuit. It mixes concentrates with purified water, heats and deaerates the dialysate, and uses balancing chambers to control ultrafiltration. The BlueStar version adds automation such as auto priming, internal conductivity testing and assisted reinfusion, with options for bibag dry bicarbonate, CDX and Crit-Line monitoring.

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The model

Maker, model and type.

Maker: Fresenius Medical Care North America (Fresenius USA, Inc.)
Model: 2008T and 2008T BlueStar Hemodialysis Machine
Device type: Haemodialysis Machine
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Dialysate flow settings	100 to 800 mL/min in steps (100, 150, 200, 300 to 800), with Auto Flow at 1.5x or 2.0x blood pump rate	Source
Net fluid removal range	0 to 4000 mL/hr	Source
UF accuracy at 500 mL/min dialysate	Within 1% of UF rate plus 30 mL/hr on total volume removed	Source
Dialysate temperature	35 to 39 C set range, accuracy 0.3 C, alarm window 2 C either side of set point	Source
Sodium and bicarbonate ranges	Na+ 130 to 155 mEq/L; bicarbonate 20 to 40 mEq/L; conductivity monitoring accuracy 1.5%	Source
Heparin pump	0 to 9.9 mL/hr, accuracy 5%	Source
Treatment time	Haemodialysis 0 to 9:59 hours; SLED fixed at 12 hours	Source
Bloodlines	6.35 mm and 8 mm bloodlines; any dialyser with ISO 8637 connectors	Source
Patient weight limit	Not for patients under 20 kg; low volume option for 20 to 40 kg	Source
Regulatory class	FDA Class II, 21 CFR 876.5860, product code KDI	Source

Recalls

Known FDA recalls.

Z-1618-20142014-04-25
Machines with Revision K Actuator-Test boards could fail to detect a disconnected UF pump.
FDA record
Z-1325-20162016-03-10
Added warning about false blood leak alarms in patients treated with hydroxocobalamin.
FDA record
Z-1026-20172016-12-21
A cancelled UF rate, goal or time change could be executed instead of the displayed value.
FDA record
Z-0829-20182017-10-05
UF goal of 0 caused displayed and actual UF pump rate to differ.
FDA record
Z-1529-20202020-01-29
Honeywell pressure transducers replaced with improved design due to reliability complaints.
FDA record
Z-1748-20202020-03-12
False Remove USB Device 2 alarm with no or unpowered USB device at the rear port.
FDA record
Z-0734-20232022-07-27
Software 2.74 issue and UI-MICS board EMI sensitivity on CDX machines causing false alarms.
FDA record
Z-0028-20242023-09-06
Potential PCBA leaching from tubing of 2008T machines (one of a set of entries covering all configurations).
FDA record

Safety

Safety warnings from the record.

Turn the machine off before replacing a circuit board or unplugging ribbon cables, unplug it before working on the power supply, and use ESD precautions in the card cage. Source
Do not use the machine for patients under 20 kg, for plasma replacement, or for therapies using substitution fluid. Source
On affected software, cancelling a UF rate, goal or time change with the escape key could still apply the cancelled rate; check software level against the correction. Source
Setting the UF goal to 0 on affected software caused a mismatch between displayed and actual UF pump rate. Source
Fresenius issued a correction in 2023 about possible PCBA leaching from tubing in 2008T machines; check the status for each serial number. Source

Sources

Where this note comes from.

Not covered: The 2008T Technician's Manual (P/N 490130) and the operator's manual alarm list were not reviewed, and the blood pump error code table in Appendix D of the troubleshooting guide is an image that could not be read, so numeric blood pump codes are not listed.

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.

Haemodialysis Machine