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Open, Classified

Hemodialysis Delivery System, Software Version 2.x.

FDA Recall Z-0215-2022 · Posted None

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeKDI
Date Initiated2021-09-29
Product Quantity4248

Reason for Recall

If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.

Firm Action

An Urgent Medical Device Correction communication was sent to affected customers via U.S.P.S., first class mail, on 09/29/2021. Baxter advises the following: 1. Operators may continue to safely use the PrisMax System with software version 2.x until the system is upgraded to version 3.x. To ensure patient safety, operators must follow the Operator s Manual and confirm all prescription fields are accurate prior to starting treatment, or when making prescription changes during therapy. The instructions can be found in the PrisMax Operating Instructions section of the Operator s Manual. Additionally, follow the onscreen reminders to periodically check patient blood chemistry. 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 Service 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. If you received this communication directly from Baxter, acknowledge receipt of this letter by completing a reply form on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com/. Log in to the portal using the account number listed at the top of the enclosed reply form instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor, please note that the Baxter 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. 5. If you distribute this

Root Cause

Software design

Distribution Pattern

Distributed nationwide to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC,SD, TN, TX, UT, VA, WA, WI and internationally to Mexico, Brazil, Canada, Australia, Singapore, Hong Kong, Vietnam, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190910PrisMax System Version 2Baxter Healthcare Corp · 2019-07-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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