FDA Recall Terminated

The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

Recall: Z-1151-2021 · Initiated January 7, 2021

Recall

Recall Number: Z-1151-2021
Event Number: 87147
Firm: Baxter Healthcare Corporation
FEI Number: 1417572
Product Code: KDI
Status: Terminated
Root Cause: Under Investigation by firm
Initiated: January 7, 2021
Terminated: April 30, 2024
Address: 1 Baxter Pkwy, Deerfield, IL, 60015-4625

Description

Reason

Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing is normally replaced during annual preventative maintenance. Alarm Situations: During System Self-Test: Alarm code B1215 (ARPS Self-Test failure); During Therapy: B1273 (ARPS Leak), B1215 (ARPS Pressure self-test), B1116 (Return Pressure self-test Failure), B1539 (Access Pod Reposition Failure), B1541 (Effluent Pod Reposition Failure), B1540 (Effluent Filter Pod Reposition Failure). If an alarm occurs, it may lead to delay or interruption of therapy. In the event that therapy is terminated without returning blood to the patient, blood loss may occur.

Action

Baxter sent An Urgent Medical Device Correction letter dated January 7, 2021. To prevent potential alarm situations, the affected tubing in the ARPS Pump Assembly for the PrisMax devices will be replaced with improved tubing. Operators may continue to safely use the PrisMax System until the tubing is replaced within the ARPS Pump Assembly. If an alarm occurs, the PrisMax System will default to a safe state and the user should follow the on-screen instructions to end treatment and to contact service. A local Baxter service representative will contact each facility to determine the correction plan and schedule the replacement for the impacted devices only. Facilities involved will be receiving this replacement from Baxter at no charge. If you received this communication directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by e-mailing it to [email protected]. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you do not return the customer reply form, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 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. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box on the reply form. For general questions regarding this communication, contact Baxter Corporate

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Austria, Belgium, Canada, China, Croatia, Denmark, Finland, France, Germany, Israel, Italy, Japan, Jordan, Kenya, Korea (Republic Of), Kuwait, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Spain, Sweden, United Kingdom.

Quantity

2314 units