—#192632

Product

PrisMax System, Product Code 955626

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: GTIN 00085412639499, All Serial Numbers

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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."

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2022-03-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192632. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.