baxter PrisMax V2 - User Manual

FA-2020-064 Baxter is a registered trademark of Baxter International, Inc. Page 1 of 2
Urgent Field Safety Notice
PrisMax, V2, ROW
FA-2020-064
Safety Alert
January 2021
Dear Healthcare Provider
Problem
Description
In an effort to keep you informed of important product information that can help ensure
the safe and effective use of our products, Baxter Healthcare is issuing a Safety Alert
for the PrisMax System. Baxter has received reports of users who have confused the
acronyms for Pre-Blood Pump (PBP) and Patient Fluid Removal (PFR) when entering
the prescriptions on the PrisMax Graphical User Interface (GUI).
During setup, the user needs to enter the Pre-Blood Pump (PBP) and the Patient Fluid
Removal (PFR) flow rates. Please ensure the appropriate values are entered in the
respective fields. Color coding and an additional help button are available for further
support when entering the prescription. Please confirm the entered Pre-Blood Pump
and Patient Fluid Removal values on the Review screen. Switching these two flow
rates may result in excessive fluid removal from the patient.
The acronyms for PBP and PFR are defined in the Operator’s Manual as well as during
therapy on the GUI screen. Refer to the enclosure for details.
To ensure patient safety, the device should only be used by a trained operator.
Affected
Product
Product Code
Product Description
Serial Numbers
955558
PrisMax V2, ROW
All
Hazard
Involved
Incorrect therapy settings could lead to unintended excessive fluid removal during
treatment. This has the potential to lead to hypotension. There have been two reports
of serious injury related to this issue.
Actions to be
Taken by
Customers
1. To ensure patient safety, the device should only be used by a trained operator per
the instructions in the Operator’s Manual. Please ensure that every operator of
this device is made aware of this Safety Alert.
2. If you purchased this product directly from Baxter, complete the enclosed
Baxter Customer Reply Form and return it to Baxter by faxing it or scanning
it. Returning the customer reply form promptly will confirm your receipt of this
notification and prevent you from receiving repeat notices.
3. If you purchased this product from a distributor, please note that the Baxter
customer reply form is not applicable. If a reply form is provided by your distributor
or wholesaler, please return it to the supplier according to their instructions.
4. If you distribute this product to other facilities or departments within your institution,
please forward a copy of this communication to them.

Summary

Safety Alert Overview

Problem Description

Users confused acronyms for Pre-Blood Pump (PBP) and Patient Fluid Removal (PFR) on the GUI, potentially switching flow rates.

Hazard Involved

Incorrect therapy settings can lead to unintended excessive fluid removal, causing hypotension and serious injury.

Affected Product and Actions

Affected Product Details

PrisMax V2, ROW (Product Code 955558, Serial Numbers All) is affected by this safety alert.

Customer Actions Required

Ensure trained operators, forward communication to others, and return Baxter Customer Reply Form.

Overview

1. Function Description
2. Usage Features
3. Maintenance Features

The Baxter PrisMax System is a medical device designed for continuous renal replacement therapy (CRRT) and therapeutic plasma exchange (TPE). It is intended for use by trained operators in a clinical setting to manage patients with acute kidney injury or other conditions requiring blood purification. The system facilitates the removal of excess fluid, electrolytes, and uremic toxins from the patient's blood, or the exchange of plasma components, through an extracorporeal circuit.

Function Description:

The PrisMax System operates by continuously circulating a patient's blood through a specialized filter or plasma separator outside the body. This process involves several key components and functions:

• Blood Pump: The system incorporates a blood pump that draws blood from the patient, propels it through the extracorporeal circuit, and returns it to the patient. The flow rate of this pump is precisely controlled to ensure effective therapy while maintaining patient safety.
• Fluid Management System: A sophisticated fluid management system is central to the PrisMax's operation. It precisely controls the delivery of replacement fluids, dialysate, and anticoagulant solutions, as well as the removal of ultrafiltrate (excess fluid) or spent plasma. This system relies on accurate pump control and weight-based fluid balancing to achieve the prescribed fluid goals.
• Filter/Plasma Separator: Depending on the prescribed therapy (CRRT or TPE), the system utilizes either a hemofilter/hemodiafilter or a plasma separator. These components are designed to selectively remove specific substances from the blood or separate plasma from cellular components.
• Anticoagulation Delivery: To prevent clotting within the extracorporeal circuit, the PrisMax System can deliver anticoagulant solutions, such as citrate or heparin, directly into the blood path. The delivery rate is adjustable and monitored to maintain optimal anticoagulation without increasing the risk of bleeding in the patient.
• Safety Monitoring: The system is equipped with multiple safety monitors to ensure the integrity of the extracorporeal circuit and patient well-being. These include pressure sensors to detect occlusions or disconnections, air detectors to prevent air embolism, and temperature sensors. Alarms are triggered if any parameter deviates from the safe operating range, prompting immediate operator intervention.
• Graphical User Interface (GUI): The PrisMax features a user-friendly GUI that allows operators to easily set up, monitor, and adjust therapy parameters. The interface displays real-time data, therapy status, and alarm messages, providing comprehensive oversight of the treatment.

Usage Features:

The PrisMax System is designed with several features to enhance ease of use and improve clinical workflow:

• Intuitive Setup: The GUI guides the operator through a step-by-step setup process, making it straightforward to initiate therapy. This includes prompts for entering patient-specific data, selecting therapy modes, and setting prescription parameters.
• Prescription Entry and Review: Operators can enter specific flow rates for various pumps, such as the Pre-Blood Pump (PBP) and Patient Fluid Removal (PFR). The system provides clear fields for these entries and includes a "Review" screen to confirm all entered values before therapy initiation. This helps prevent errors such as confusing PBP and PFR values, which could lead to excessive fluid removal.
• Color Coding and Help Features: To further assist operators in accurate prescription entry, the GUI incorporates color coding for different parameters and an additional help button. These visual cues and on-demand information aim to reduce the likelihood of input errors.
• Multiple Therapy Modes: The PrisMax supports various CRRT modalities, including continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), and continuous venovenous hemodiafiltration (CVVHDF), as well as TPE. This versatility allows clinicians to tailor therapy to individual patient needs.
• Automated Priming and Recirculation: The system offers automated priming and recirculation functions, which streamline the preparation process and reduce manual steps, thereby saving time and minimizing the risk of contamination.
• Real-time Data Display: During therapy, the GUI continuously displays critical parameters such as blood flow rate, ultrafiltration rate, fluid balance, and pressures within the circuit. This real-time feedback enables operators to closely monitor the patient's response and make timely adjustments.
• Alarm Management: The system's alarm system is designed to be clear and informative, providing specific messages that guide operators to the root cause of an alarm and suggest appropriate actions.
• Data Logging and Reporting: The PrisMax System automatically logs therapy data, which can be retrieved for review, reporting, and electronic medical record integration. This feature supports comprehensive patient management and quality assurance.

Maintenance Features:

While the PrisMax System is primarily operated by clinical staff, certain aspects contribute to its overall maintainability and longevity:

• Modular Design: The system's modular construction facilitates easier troubleshooting and component replacement by trained service personnel.
• Self-Diagnostics: The PrisMax incorporates self-diagnostic capabilities that can identify potential issues within the system, alerting service technicians to specific problems and aiding in efficient repair.
• Software Updates: The system's software can be updated to incorporate new features, improve performance, and address any identified issues, ensuring the device remains current with best practices and technological advancements.
• Cleaning and Disinfection Protocols: The manufacturer provides detailed instructions for cleaning and disinfecting the external surfaces of the device, which are crucial for maintaining hygiene in a clinical environment and preventing cross-contamination.
• Preventive Maintenance Schedule: A recommended preventive maintenance schedule is typically outlined in the device's service manual. Adhering to this schedule, performed by qualified service technicians, helps ensure the continued safe and effective operation of the PrisMax System over its lifespan. This includes regular checks of pumps, sensors, and other critical components.
• Consumable Management: The system is designed to work with specific disposable sets (e.g., bloodlines, filters, fluid bags). The design of these consumables and the loading process are engineered to be straightforward, minimizing the risk of incorrect setup and facilitating efficient replacement during therapy.
• Operator Training: While not a direct maintenance feature of the device itself, comprehensive operator training is a critical aspect of ensuring the device's proper use and minimizing wear and tear due to misuse. Trained operators are better equipped to identify and address minor issues, reducing the need for service interventions.

baxter PrisMax V2 Specifications