Class 2 Device Recall PrisMax System

• Date Initiated by Firm: March 15, 2022
• Create Date: April 22, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0992-2022
• Recall Event ID: 89823
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: PrisMax System, Product Code 955724
• Code Information: GTIN 07332414126018, All Serial Numbers
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System will return the patient Gain/Loss Limit or the RDL to the default value, rather than the non-default value entered at the initiation of treatment. The PrisMax System interface will display the original values once treatment is restarted but does not have an alert to inform the user of the change. The RDL value will be returned to the original value immediately upon selecting the Same Patient function. The Gain/Loss Limit value will be returned to the original value when the patient weight and/or hematocrit is changed during treatment.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm notified its consignees be letter on 03/15/2022. The following instructions were provided: "1. Operators may continue to safely use the PrisMax System. To ensure patient safety, there are two approaches to address the anomalies: ¿ Approach 1: Choose new patient at every filter set change. This will require re-input of all prescription settings and therapy will begin without prescription settings and treatment data from the previous filter set. ¿ Approach 2: Choose Same Patient when changing a filter set. Check and correct the Gain/Loss Limit or RDL prior to starting treatment. ¿ See Attachment A to change the Gain/Loss Limit ¿ See Attachment B to change the RDL 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 Urgent Medical Device Correction. 2. When the software upgrade becomes available, a local Baxter representative will contact your facility to determine the correction plan and schedule the upgrade for impacted devices. Your facility will be receiving this upgrade from Baxter at no charge. 3. Acknowledge the receipt of this notification by completing a reply form on the customer portal."
• Quantity in Commerce: 296 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Mexico, Brazil, Jamaica, Trinidad and Tobago, Canada, Australia, Singapore, Hong Kong, Vietnam, New Zealand, Korea, Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.