Model note · Haemodialysis Machine
Baxter Prismaflex System
The Prismaflex is a continuous renal replacement machine for intensive care. It runs SCUF, CVVH, CVVHD, CVVHDF and therapeutic plasma exchange for patients from 20 kg, using dedicated sets (M60, M100, M150, HF1000, HF1400, ST sets, TPE 2000) that it loads and primes itself. Five pumps (blood, pre blood, replacement, dialysate, effluent) and four scales control fluid balance, so scale accuracy and room temperature matter as much as the pumps. It does not control dialysate temperature or conductivity. Most reported problems are leaks, breaks and cracks in the disposable set. Field actions covered pump module electronics, the ARPS repositioning pump tubing, communication errors and connector use.
The model
Maker, model and type.
- Maker
- Baxter Healthcare Corporation (originally Gambro Renal Products)
- Model
- Prismaflex System (control unit, software 8.10) for CRRT and TPE
- Device type
- Haemodialysis Machine
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA classification and clearances | High permeability dialyser system, product code KDI; K041005 (2004) onward; K131516 (2014, software 7.10); K171671 (23 February 2018, software 8.10); K212216 (2022, ST sets) | Source |
| Therapies and patients | SCUF, CVVH, CVVHD, CVVHDF and TPE for patients weighing 20 kg or more; all treatments prescribed by a physician | Source |
| Blood flow | 10 to 450 mL/min; accuracy plus or minus 10% of set rate at 450 mL/min (or the set's highest flow) at 37 degrees C and -200 mmHg access pressure | Source |
| Fluid flows | Dialysate and replacement 0 to 8000 mL/h in 50 mL/h steps (replacement 0 to 5000 mL/h in TPE); pre blood pump 0 to 4000 mL/h CRRT, 0 to 1000 mL/h TPE; effluent up to 10000 mL/h; each pump accurate to plus or minus 30 mL/h | Source |
| Patient fluid removal | 0 to 2000 mL/h CRRT, 0 to 1000 mL/h TPE, 10 mL/h steps; accuracy plus or minus 30 mL/h, 70 mL per 3 h, 300 mL per 24 h, with scales calibrated at the room temperature of use and less than 3 degrees C change during treatment | Source |
| Pressure limits | TMP alarm user settable +70 to +350 mmHg (default +350) in CRRT; TMPa +50 to +100 mmHg (default +100) in TPE | Source |
| Anticoagulation | Syringe pump for 20, 30 and 50 mL syringes, continuous or bolus | Source |
| Physical | About 78 kg without bags or set; about 163 cm high, 49 cm wide, 70 x 70 cm base; ECG discharger fitted; sends data to a PDMS | Source |
Recalls
Known FDA recalls.
- Z-1224-20262026-01-06
ST100 set deaeration chamber may dislodge from the control unit.
FDA record - Z-2378-20212021-07-22
Sets labelled sterile may not have been sterilised (contract steriliser data manipulated).
FDA record - Z-1277-20212021-01-28
ARPS pump assembly tubing variability can cause alarms during or after self test.
FDA record - Z-0276-20202019-10-04
Software below 7.21: communication error alarms may interrupt therapy or prevent blood return.
FDA record - Z-0759-20192018-09-06
PRISMAFLO II heating profile damage may cause a hotspot and low level skin burn.
FDA record - Z-1922-20182018-04-24
Pump module electronics failure mode (Voltage Out of Range); new firmware on all control units.
FDA record
Safety
Safety warnings from the record.
- The Prismaflex does not control dialysate conductivity or temperature; the bags' composition and any warming are the user's responsibility. Source
- In 2021 some M60, M100 and other sets labelled sterile may not have been sterilised because a contract steriliser falsified data; check set lots against the recall. Source
- Follow the operator's manual for safe unloading of sets; for software 5.10 and 6.10 the programmed syringe size also needed checking (2017). Source
Sources
Where this note comes from.
- FDA 510(k) K171671 summary, Prismaflex System 8.10
- openFDA device recall records for Prismaflex
- openFDA MAUDE problem counts for Prismaflex
Not covered: The operator's and service manuals were not read, so the alarm list, scale calibration steps and preventive maintenance intervals are not included. The design note reads the four scale layout from the clearance table; check the exact scale count against the operator's manual.
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
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