Baxter Gambro Prismaflex System
Baxter International · Model Gambro Prismaflex System
A single system for all CRRT therapies, including SCUF, CVVH, CVVHD, CVVHDF, and TPE. Industry-leading fluid management accuracy. Integrated design functions for effective anticoagulation management. Convenient and simple oversight of pre- and post-dilution mixing points through two integrated pinch clamps. Multiple fluid therapeutic combinations and optimum dose delivery capabilities through a high flow-rate pump and four fluid pumps.
Key tips
- ·Conductivity and water-quality checks are non-negotiable before every shift - dialysate chemistry errors are a direct patient-harm mechanism.
- ·Confirm disinfection cycle completion, never assume it, after every use.
- ·Treat a blood-leak detector fault as real until proven otherwise - never silence and continue.
Typical Failure Modes
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Conductivity / temperature / dialysate-prep alarm
HighSymptoms: Conductivity or temperature out of range, dialysate-preparation alarm, treatment will not start.
Root cause: Concentrate connection / supply, a heater fault, a conductivity-cell fault, or a proportioning-pump / valve fault.
Blood or dialysate pump fault
MediumSymptoms: Pump will not run at set speed, occlusion or flow alarms, tubing walking in the raceway.
Root cause: Worn pump rotor / rollers or a motor / control fault.
Pressure-monitoring / air-detector fault
MediumSymptoms: Venous / arterial / TMP pressure implausible, air-detector false alarms or fails to detect.
Root cause: Transducer-protector wetting, a pressure-sensor fault, or an air-detector fault.
UF / balancing-chamber fault
MediumSymptoms: Fluid-balance / UF alarms, weight loss inaccurate, balancing-chamber leak.
Root cause: Balancing-chamber diaphragm / valve wear or a flow-sensor fault.
Disinfection / rinse fault
MediumSymptoms: Heat or chemical disinfection will not complete, residual disinfectant test fails.
Root cause: Heater, a dosing / rinse valve, or a conductivity-verification fault.
Serviceable Parts & Consumables
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
Blood / dialysate pump rotor & rollers
Class Periodic replacementRel. cost $$R&R Moderate
Conductivity cell / temperature sensor
Class Periodic replacementRel. cost $$R&R Moderate
Pressure sensors / transducer protectors
Class Periodic replacementRel. cost $$R&R Fairly easy
Balancing-chamber diaphragm / valve kit
Class Periodic replacementRel. cost $$$R&R Difficult
Proportioning pump / valves
Class Major service partRel. cost $$$R&R Difficult
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Blood / dialysate pump rotor & rollers | Periodic replacement | $$ | Moderate |
| Conductivity cell / temperature sensor | Periodic replacement | $$ | Moderate |
| Pressure sensors / transducer protectors | Periodic replacement | $$ | Fairly easy |
| Balancing-chamber diaphragm / valve kit | Periodic replacement | $$$ | Difficult |
| Proportioning pump / valves | Major service part | $$$ | Difficult |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Disinfection cycle verification
- ·Conductivity and water-quality check
- ·Blood-leak detector test
- ·Scheduled tubing / filter replacement
- ·Annual full PM
Troubleshooting Approach
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Conductivity or temperature alarm
- Confirm the concentrate is connected, correct and not empty.
- Verify dialysate conductivity and temperature with independent calibrated meters.
- Check / calibrate the conductivity cell and temperature sensor.
- Inspect the proportioning pumps / valves and de-air the hydraulics.
- Do not treat until conductivity and temperature are verified in range.
Symptom: Pump or pressure fault
- Inspect the pump rotor and rollers for wear and correct occlusion.
- Reseat the tubing segment in the raceway.
- Check the pressure transducers and protectors for wetting.
- Calibrate the pressure channels.
- Replace the rotor / rollers or a faulty sensor as isolated.
Technical Specs
- Height
- 64 in
- Length
- 12 in
- Weight
- 132 lbs
- Width
- 19 in
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Dialysis unit / clinic
- ICU (acute dialysis)
- Home hemodialysis
Documents & Manuals
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
- RECALL
Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter. Data was manipulated to appear to be conforming
- RECALL
Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.
- RECALL
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
- RECALL
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
- RECALL
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
- RECALL
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
- RECALL
Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentionally.
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