baxter PrisMax V2 - User Manual

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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.

Need help?

Do you have a question about the baxter PrisMax V2 and is the answer not in the manual?

baxter PrisMax V2 Specifications

General

Device Type	Continuous Renal Replacement Therapy (CRRT) System
Manufacturer	Baxter International Inc.
Power Requirements	100-240 VAC, 50/60 Hz
Effluent Flow Rate	0 to 8000 mL/hr
Heparin Infusion Rate	0-10 mL/h
Pressure Monitoring	Yes
Air Detection	Ultrasonic air detector on the return line with automatic pump stop
Blood Leak Detection	Optical blood leak detector in the effluent line with automatic pump stop
User Interface	Touchscreen
Anticoagulation	Heparin or Citrate
Connectivity	Ethernet
Safety Features	pressure monitoring, air detection, blood leak detection
Intended Use	The PrisMax system is intended for continuous renal replacement therapy (CRRT), sustained low efficiency dialysis (SLED), and therapeutic plasma exchange (TPE) therapies. It is intended for use in patients with acute kidney injury or fluid overload.