FA-2020-064
Baxter is a registered trademark of Baxter International, Inc.
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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.
