Essentia / Devices / Haemodialysis Machine
Device Lab 22
Haemodialysis Machine
An extracorporeal blood circuit exchanges across a hollow-fibre membrane against a separate prepared dialysate stream. Access, blood handling, fluid preparation and protective sensing are different parts of the same treatment system.
Also called: Dialysis Machine, Hemodialysis Machine, Hemodialysis, Haemodialysis, Kidney Machine. Arabic: جهاز غسيل الكلى الدموي. Device Lab 22 of 69 in BMEssentia Medical City, 1 configurations.
Overview: the configurations
Hemodialysis
An extracorporeal blood circuit exchanges across a hollow-fibre membrane against a separate prepared dialysate stream. Access, blood handling, fluid preparation and protective sensing are different parts of the same treatment system.
Automated peritoneal dialysis
A pneumatic cycler moves dialysis solution through a disposable cassette and a single patient catheter. Fill, dwell and drain are separate phases; the peritoneum provides the exchange surface and blood remains inside the body.
Manual peritoneal dialysis
A gravity exchange set connects fresh solution, a patient transfer set and a drain bag. There is no powered cycler. The patient connection, bag heights, clamp states and clean connection workflow determine what can happen.
How it works: the main parts
What each part does, from the Haemodialysis Machine lessons in the 3D Device Lab.
- Housing
- It is a box. That is the point, and it is why people stop looking at it.
- Display
- You will be tempted to call this the brain. It is not.
- Blood pump
- The machine never touches the blood. Read that again, because almost every wrong mental model of this pump starts by forgetting it.
- Heparin
- Blood that meets a plastic surface tries to clot. The entire extracorporeal circuit is one long plastic surface, so without anticoagulation the dialyzer would progressively clot off during treatment.
- Dialyzer
- Everything else in this room exists to get two liquids to this cartridge under the right conditions. The dialyzer is where the treatment actually happens, and it happens across a membrane you will never see.
- Venous safety
- Air in the venous line is one of the few failures in this circuit that can injure a patient in seconds. Everything in this assembly exists for that single scenario.
- Pressure
- These two thin branches are not delivering anything. They are the machine's only direct sense of what is happening inside a circuit it otherwise cannot see.
- Saline
- A clear bag of clear fluid hanging beside a machine full of other clear fluids. This is the single easiest component in the room to misidentify, and misidentifying it is not harmless.
Common faults and what to check
Most reported device problems (FDA MAUDE)
| Device problem | Reports |
|---|---|
| Device Alarm System | 124 |
| Output, high | 74 |
| Replace | 70 |
| Inadequate Ultra Filtration | 54 |
| Self-Activation or Keying | 49 |
| Air Leak | 44 |
Raw counts of adverse event reports for this device type (FDA product code FKP), all years. Not adjusted for the number of units in use, so they show what gets reported, not failure rates. Report text is never copied.
Standards engineers test against
IEC 60601-2-16: haemodialysis, haemodiafiltration and haemofiltration equipment
The particular standard for dialysis machines.
ISO 23500: water and fluids for haemodialysis
The series that sets the quality of water for dialysis, concentrates and dialysis fluid, and how the water treatment system is validated and monitored.
Recent FDA recalls
| Recall | Product and reason |
|---|---|
| Z-2224-2010 2010-08-15 | Fresenius Medical Care North America: Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy. Root cause: Component design/selection. |
| Z-2227-2010 2010-08-15 | Fresenius Medical Care North America: Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy. Root cause: Component design/selection. |
| Z-1322-2010 2010-04-12 | Baxter Healthcare Renal Div: Baxter 1550 Single Patient System Hemodialysis Machines Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software. Root cause: Software change control. |
| Z-2352-2008 2008-09-21 | Hach Co: HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Tests for feed water and rinse water Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results Root cause: Nonconforming Material/Component. |
| Z-2353-2008 2008-09-21 | Hach Co: HACH SteriChek Sensitive Total Chlorine Reagent Strips, Tests for water and rinse water down to 0.1 mg/l (ppm), packaged Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results Root cause: Nonconforming Material/Component. |
From the FDA recall database (openFDA), newest first, imported 2026-10-22. 12 recalls on record for this device type. Recall text is the FDA's public text; each recall links to the official record.
Learn it, see it in 3D, ask about it
- Ask Essentia about the Haemodialysis Machine: answers from named sources, with the device open in its 3D Device Lab beside the answer.
- The Haemodialysis Machine on the BMEssentia Platform: the Device Library course, 13 sections from physics to maintenance.
- BMEssentia Medical City: Device Lab 22, the Haemodialysis Machine fully assembled in 3D, with lab tasks and the simulations.
Previous: PCNL System. Next: Peritoneal Dialysis. All 69 devices.
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