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
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is recalling the tubing in the Automatic Repositioning System (ARPS) Pump Assembly for the PrisMax System Version II Hemodialysis Delivery System due to variability in tubing performance. The affected tubing is used in three model numbers (955626, 955558, and 9557) and approximately 2,314 units have been distributed worldwide, including across the United States and multiple international countries. The faulty tubing may cause various alarm codes to appear during system self-testing or during therapy, including alarms related to ARPS self-test failures, leaks, pressure tests, and repositioning failures.
If alarms occur, therapy may be delayed or interrupted. In cases where therapy is terminated without returning blood to the patient, blood loss may occur. The recall record does not specify a remedy or required action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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, Quantity: 2314 units Lot/code info: Model Numbers: serial number, UDI; a) 955626: 101227, (01) 00085412639499 (21) 101227; 101280, (01) 00085412639499 (21) 101280; 101292, (01) 00085412639499 (21) 101292; 101293, (01) 00085412639499 (21) 101293; 101327, (01) 00085412639499 (21) 101327; 101348, (01) 00085412639499 (21) 101348; 101352, (01) 00085412639499 (21) 101352; 101353, (01) 00085412639499 (21) 101353; 101389, (01) 00085412639499 (21) 101389; 101391, (01) 00085412639499 (21) 101391; 101393, (01) 00085412639499 (21) 101393; 101394, (01) 00085412639499 (21) 101394; 101398, (01) 00085412639499 (21) 101398; 101422, (01) 00085412639499 (21) 101422; 101423, (01) 00085412639499 (21) 101423; 101450, (01) 00085412639499 (21) 101450; 101452, (01) 00085412639499 (21) 101452; 101456, (01) 00085412639499 (21) 101456; 101791, (01) 00085412639499 (21) 101791; 102142, (01) 00085412639499 (21) 102142; 102151, (01) 00085412639499 (21) 102151; 102152, (01) 00085412639499 (21) 102152; 102153, (01) 00085412639499 (21) 102153; 102154, (01) 00085412639499 (21) 102154; 102155, (01) 00085412639499 (21) 102155; 102159, (01) 00085412639499 (21) 102159; 102312, (01) 00085412639499 (21) 102312; 102318, (01) 00085412639499 (21) 102318; 102326, (01) 00085412639499 (21) 102326; 102328, (01) 00085412639499 (21) 102328; 102329, (01) 00085412639499 (21) 102329; 102330, (01) 00085412639499 (21) 102330; 102353, (01) 00085412639499 (21) 102353; 102356, (01) 00085412639499 (21) 102356; 102364, (01) 00085412639499 (21) 102364; 102365, (01) 000854
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.